Key Attraction

novel ideas for advancements in medical device technologies without compromising their safety and effectiveness. This summit brings together some of the renowned R&D experts and technology innovators to share information regarding opportunities, obstacles, best practices and challenges in the development of the new devices. Attendees will get insight into device innovation trends and upcoming changes in the medical device regulations.
for successfully executing regulatory inspections by providing industry best practices. Panel discussions led by the former FDA office bearers and industry experts will provide a set of comprehensive strategies on how to prepare for and manage an FDA inspection, including how to follow-up and closing out 483s or Warning Letters. Attending this summit will enable you to improve and better prepare for your next inspections.
FDA compliant quality management systems. Attend this summit to learn how to develop and implement effective, consistent and reliable quality management systems. Ex-FDA officials and senior company executives will share thoughts and ideas to improve the performance of your current system.
with leading minds in the industry. Attendees will get to network with the prominent decision makers in the industry to exchange ideas, offer thoughts and know-how, and share experiences. Joining this summit will offer a unique opportunity to the attendees to market their offerings and identify new business opportunities.
the current state of medical device laws and technology and government oversight. Panel comprising of some of leading medical device experts and veterans will discuss the recent changes to the regulatory environment for the medical device industry and how these changes will impact the approval of new devices. Attendees will gain insight into the current issues and future challenges in the industry. Join this summit to hear from the experts who have extensive experience in all aspects of medical device including R&D, manufacturing quality assurance, approval and commercialization process.
factors for successful medical device commercialization. Discussions with industry veterans through real case studies will help medical researchers, healthcare professionals, industrialists and entrepreneurs' better understand the criteria's for successful commercialization of medical devices. This summit also offers numerous opportunities for medical device companies and suppliers to showcase their products and services to potential customers, generating leads and growing their businesses.
risk management strategies for the safe, effective and efficient use of medical devices. Medical device professionals will join together to share their knowledge and best practices for implementing good risk management principles within the industry. Attending this summit will help you to develop a robust and integrated risk management plan to improve quality management system.

Find out who had attended the Medical Device Summit in past, by completing the short form below.



Why you should attend this summit

  • Future Trends of Medical Device Regulation, Risk Management, UDI, Recall Complaint Management etc.
  • Listen from FDA/CDRH Directors:
    • What is Critical to Quality
    • Get Update on FDA compliance
  • Listen from FBI:
    • Cyber Security Risks
  • Learn More about Medical Device Global Regulatory Landscape and Off-label Promotion
  • Explore Upcoming Changes in Medical Devices under Trump Administration
  • Change Management
  • Criteria for Supplier Quality Agreement
  • Establishing a Medical Device Security Program
  • Panel Discussion
    • FDA Warning Letter
    • FDA Enforcement
    • FDA Interaction

Who Will Benefit?

  • Quality Assurance/Quality Control
  • Manufacturing and Contracting
  • Supply Chain Management
  • Import/Export
  • Sales, Marketing and Business Development
  • IT and Software
  • Risk Management and Product Lifecycle Management
  • Executive Management
  • Regulatory Affairs
  • Research and Development
  • Engineers
  • Scientists
  • Documentation
  • Compliance Officers
  • Clinical/Lab
  • Consultants/Service Providers/Suppliers
Summit Experience

Past Sponsors, Exhibitors and Media Partners

Medical Device Summit Partners & Sponsors


The ComplianceOnline Medical Device Summit will include the following:

Keynote Addresses

Leading medical device experts and company executives give their view of the current issues and future challenges in the industry.

Focused Workshops

Expert-led workshops that will help those medical device professionals starting out in their careers and even more senior professionals who need to brush up on new technologies, regulations, processes and more.

Panel Discussions

Panels comprising some of the well-known thinkers and innovators in medical device technology, regulatory compliance and quality will discuss and debate the hottest issues that are affecting the industry. Attendees will be able to interact with panel members during these debates and get unparalleled insight into the state of the industry.

Networking Sessions

Attendees will get to interact with and meet the leading decision makers in the industry in order to exchange ideas, discuss business opportunities and share strategies in focused, small groups.

Multiple Tracks

The Summit will have event tracks dedicated to topics affecting each division/segment of the medical device industry

Exhibitors' Stalls

A unique opportunity for medical device companies both big and small to market their offerings and identify new business opportunities.

Post-Event Community Access

Attendees will get access to an online community that ensures they can continue to build on the networking opportunities and interest that began during the event.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
8:00 - 8:30 AM

Registrations and Breakfast

8:30 - 8:45 AM

Welcome Speech with an Introduction of ComplianceOnline & Summit

8:45 - 9:10 AM

FDA Enforcement – Outlook & Implications - Keynote

FDA Invited (ORA)
9:15 - 9:45 AM

CDRH Office of Compliance Strategic Priorities and Hot Topics in Compliance - Keynote

FDA Invited (CDRH)
9:45 - 10:15 AM

Current Healthcare Eco System: Challenges & Opportunities - Keynote

Coy Murchison, Chief Strategy Officer, Berry Herring Hayes & Associates
Ensuring HIPAA security in today’s health IT environment requires HDOs hit a daily trifecta of HIPAA compliance, cyber security, and medical device management to ensure the IT infrastructure and PHI is protected. The FDA’s Guidance states there is a shared responsibility among health care facilities, health care providers, patients, and manufacturers. This collaboration of stakeholders demands a comprehensive security plan which must align key departments: (1) Cyber Security; (2) HIPAA Privacy and Security; and (3) HTM. Because IT departments understand the IT infrastructure, HIPAA privacy departments understand OCR rules and HTM understands the functionality of the device – repair and maintenance, there must be an understanding of whom manages specific threats to the IT network and the medical device.
Learn the strategies to develop thorough strategies to lessen and alleviate OCR violations should a breach occurs:
  • Incorporate functionality systems which detect cybersecurity events in devices, in a timely manner;
  • Develop strategies to contain medical device intrusion;
  • Contain the impact of a potential cybersecurity incident;
  • Create contracts which lessen the risk of the health delivery organization;
  • Learn strategies to ensure proper management of PHI captured within the medical devices.
10:15 - 10:35 AM

Global Medical Device Regulations - US, EU, Canada, Brazil, China, Japan, Mexico, Russia, South Korea, Taiwan

John Riggi, President and CEO, Lake Ontario MED DEV Consultants
This session will cover:
  • High level review of US GMP regulations and those significant GMP regulations worldwide regarding quality systems
    • US
    • Canada
    • Brazil
    • EU
    • China
    • Japan
  • Additionally, similarities between requirements will be covered.
  • Lastly, will cover where to expect GMP regulations to implement as we move forward into 2020.
10:35 - 10:45 AM

Networking Break

10:45 - 11:20 AM

GDPR 2020: The evolution of general data protection and the rights of individuals over their own data.

L. Stephan Vincze, President & CEO, Trestle Compliance, LLC (Former Counsel, U. S. House of Representatives Committee)
Nearly two years after becoming effective, the EU General Data Protection Regulation (GDPR) has had significant effects on companies around the world. This interactive session will have a panel of experts discussing the following key issues:
  1. A quick review of key GDPR principles and requirements
  2. How has GDPR affected the rest of the world and the U.S.?
  3. Where are we/you today nearly 2 years after GDPR went live?
  4. Is it too late to become compliant?
  5. Key steps to become GDPR compliant now.
11:25 - 12:00 PM

Artificial Intelligence in Medical Device - Keynote

FDA Invited (CDRH)
12:00 - 1:00 PM


1:00 - 1:35 PM

FDA Communication Power Tools

Kwame Ulmer, Principal, Ulmer Ventures (Ex-FDA)
The US Food and Drug Administration offers a range of mechanisms to communicate with premarket review staff. The timing of communication and best practices to ensure both parties understand each other's messages is not well understood. Manufacturers regularly under-estimate the time and preparation required for effective communications for premarket applications and postmarket communications. Kwame Ulmer will highlight effective communication with FDA in a comprehensive manner to include the power tools that can be used immediately when seeking clearance, approval and effective compliance remediation.
1:40 - 2:00 PM

Medical Device Outsourcing, Supply Chain Management and new Foreign Trade Problems for Import/ Export Business

Casper E. Uldriks, Former Associate, Center Director of FDA's CDRH
Global markets create new and costly demands for a device import/export business. Firms must consider and update their short and long-term business plans to assure an effective positioning in the global market. New foreign regulatory requirements, effective quality assurance programs and evolving freight forwarding demands all require well planned in-house regulatory program to avoid expensive surprises and delays. For example, the European Union’s (EU) new Medical Device Regulation (MDR) and cybersecurity programs are hot topics for FDA that should be considered as the impact your products.
2:00 - 2:30 PM

Vendor and Supplier Qualification and Selection.

Casper E. Uldriks, Former Associate, Center Director of FDA's CDRH
Vendors and suppliers present new risks that require a systematic evaluation of their suitability for your product. You should establish and verify well defined qualification criteria to have proper management of the risks inherent in any 3rd party involvement. The FDA holds you responsible for what you accept from them and incorporate into your commercial service or product. Quality assurance functions present a core challenge to determine a domestic and foreign 3rd party’s willingness to meet your expectations. Your reliance cannot be based on blind faith. You and a third-party vendor or supplier need a dynamic relationship to avoid any manageable risk associated with your product. Key elements of a third-party quality assurance program and risk assessment practices will be identified.
2:30 - 2:45 PM

Networking Break

Track A - Sessions
Track B - Sessions
2:45 - 3:15 PM

3D Printed Medical Implants – Past, Future and… Present

David Morrow, WW Integration Leader, 3D Printed Medical Implant Systems, DePuy Synthes, Johnson and Johnson
The talk will provide audience with perspective on 3D printed medical implants & instruments current and future state. Care will be taken to highlight not only the 3D med device manufacturing evolution but also provide context on hype versus today’s reality. Talk will also highlight strategic business considerations in the 3D med device space.
The presenter will share perspective on key considerations required to successfully commercialize 3D printed medical devices. Content will also provide insights on appropriate product profiles as well as the critical role a clinical value proposition plays in driving market adoption.

MDR Implementation - Status, Next Steps and (revised) Timelines

Bill Enos, Senior Commercial Operations Director, Regulatory Services (Medical Devices) Americas, BSI Group
  1. How to prepare for May 26, 2020 for devices using the soft transition
  2. Art 120(3)
  3. Economic Operators
  4. PMS/Vigilance
  5. Market Surveillance
  6. NB audits under MDR
  7. EUDAMED status update
3:25 - 3:50 PM

Medical Device Directive (EU MDD) and Medical Device Single Audit Program (MDSAP)

Software as a Medical Device - What to consider?

Royth v. Hahn, Global head of TUV SUD’s Business Unit , Medical and Health Services (MHS)
  1. Software as a medical device under MDR
  2. Apps as medical devices
  3. Software as part of a medical device
  4. Classification under MDR
  5. App Stores in regards of economic operators: status of the discussion
4:00 - 4:40 PM

FDA Electronic Submission Process - Keynote

FDA Invited
4:40 - 4:50 PM

Closing Mark - Next Day Plan

8:00 - 8:30 AM

Registration and Breakfast

8:30 - 9:00 AM

NanoEHS Risk Assessment Lessons for Medical Devices - Keynote Speech

9:05 - 9:35 AM

Protecting Company Revenues with Product Compliance - Keynote

Kelly Eisenhardt, Managing Director & Co-Founder, BlueCircle Advisors
Hazardous material and substance regulations continue to increase across the globe. Preventing lost sales from stop shipments, fines, and fees is crucial. Kelly Eisenhardt will discuss how understanding the web of compliance requirements for customers, governments, suppliers, and products is key to protecting your company’s revenues. Learn the ten (10 ) steps to building better product compliance programs.
9:40 - 10:00 AM

Medical Device Advertising and Promotion: Compliant Marketing Communication Practices in the Age of Social Media

Howard L. Dorfman, Esq., Adjunct Professor, Seton Hall University School of Law
While advertising and promotion of medical products has long been subject to regulation by the Food and Drug Administration (FDA), the expansion of available media platforms over the past decade has created uncertainty for medical device manufacturers and others. In particular, the explosive growth of social media and the internet including Twitter and Facebook has brought both challenges as well as opportunities in terms of the delivery of promotional messaging as well as disease state information to healthcare professionals, patients and caregivers. Since FDA enforcement had originated with the more traditional methods of communication such as print, radio and television, development of guidance specifically focused on the new forms of media has been relatively slow to appear. As a result, there has been a relatively measured adoption of these new communication channels by device manufacturers and others in the medical products manufacturing community.

This presentation will explore the foundation of government oversight relative to advertising and promotion to the medical and lay communities and follow the development of FDA guidances designed to bring a degree of clarity to manufacturers electing to utilize social media. Specifically, the session will focus on the following:
  • Basic principles relating to the regulation of medical device advertising and promotion
  • Evolution of government enforcement
  • Analysis of FDA guidance documents addressing the use of social media
  • The (possible) future of advertising and promotion for medical devices
10:00 - 10:20 AM

Exploring what is new in the FDA’s approaches to premarket, post market and Recalls in the medical devices area

Haja Sittana El Mubarak, PhD, Former FDA Official, Senior IVD consultant, Biologics consulting Inc
The vision of the FDA’s Center of Devices and Radiological Health (CDRH) includes a commitment to that patients in the US have access to high-quality, safe and effective medical devices of public health importance first in the world. To this end CDRH selected strategic priorities and is implementing several advances in the pre and post market areas to; reduce the time and cost to the U.S. market, and support the devices throughout the product life cycle without compromising reasonable assurance of safety and effectiveness. This session will explore key advances and trends in the FDA’s approaches to premarket, post market and Recalls in the medical devices area.
The session will discuss premarket, post market and compliance processes with focus on the impact of the following:
  • Changes in the IDE program, NEST, Parallel review program, Partnering with patients, customer service and quality management
  • The total product life cycle approach.
  • The Simplicity approach and Least burdensome approach.
  • Collaborative communities
10:20 - 10:35 AM

Networking Break

10:35 - 11:10 AM

Emerging Technologies of the Digital Health - Panel Discussion

Jyotsna Mehta, Founder, Keva Health (Ex-FDA)
11:15 - 11:40 AM

Medical Device Enhancements - Keynote

FDA Invited (CDRH)
11:45 - 12:15 PM

Cybersecurity, Machine Learning and Iot/IIoT

Zoe Braiterman, Consultant, GYMedical Device Consulting, LLC
12:15 - 1:15 PM


1:15 - 1:50 PM

Medical Device Quality Challenges and Risk Management (ISO 13485 and ISO 14971): - Panel Discussion

Denise (Whitehead) Arrington
Joshua D. Levin
Track A - Sessions
Track B - Sessions
1:50 - 2:20 PM

Combination Products

Archana Reddy, Ex-Regulatory Advisor/Public, Health Advocate, (FDA)

Cyber Security

Charlie Schick, Business Development, Healthcare and Life Sciences, Owl Cyber Defense
2:20 - 2:50 PM

Techincal Writing and Documentation

CHANGE CONTROL - Is Your Change Management System Effective?

Stephanie Harrell, CQA (Former US FDA Investigator) Quality and Compliance Consultant, Auditor and Trainer, ProPharma Group
Controlling change in a quality system will require key tools and resources alike. In an ever evolving regulatory landscape it invites all involved participants to engage fully and embrace their part in the process.
This session will provide the following insights:
  1. How to recognize when change controls are needed
  2. Who should be involved in the change control process
  3. What resources will be needed to effectively manage change controls
  4. Remaining current with change controls as part of cGMP’s
2:50 - 3:00 PM

Networking Break

3:00 - 3:30 PM

Robotics and Artificial Intelligence (AI)

Nathan McBride, Vice President, Global IT, Orchard Therapeutics
3:30 - 3:50 PM

FDA Inspection - Keynote

FDA Invited (ORA)
3:50 - 4:15 PM

ISO 10993 and Biocompatibility - Workshop

Oleg Kornienko, External Service & Operations Quality Head, Novartis Institutes for BioMedical Research (NIBR)
4:15 - 4:35 PM

Vote of Thanks & Participation Certificate Distribution

Note: This program may be subject to alterations and additions

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

2020 Summit Speakers

Past Speakers from FDA, FBI and FDA Information Repository (IRAI)


Terri Jollymour

(Sr. Director, Operations Readiness & Convergence
Johnson & Johnson Corporate Supply Chain Quality & Compliance)

Pat Baird

Regulatory Head of Global Software Standards, Philips

Tom Loker

(Businessman | Author | Speaker, Startup Consultant and Advisor SYDK.ORG, Contributor to California Political Review)

Dr. Ron Weissman

(Chairman, Software SIG, Band of Angels)

Stan Mastrangelo

Technical Committee Member of working group on ISO 31000, ISO 14971, and ICH Q9 Standards, Professor, Center for Applied Health Sciences, Virginia Tech University

Daphne Walmer

Thought Leader/Expert/Consultant in Medical Device Labeling and Technical Communications

Michael Weickert

Strategic & Entrepreneurial Executive, Trail-blazing Leadership in Biotech, Medical Device & Pharmaceutical Business

David Nettleton

Industry Leader, Author, and Teacher for 21 CFR Part 11, Annex 11, HIPAA, Software Validation, and Computer System Validation

Geetha Rao

CEO, Springborne Lifesciences

Dan O'Leary

President at Ombu Enterprises, LLC

Nancy Van Schooenderwoert

President, and Managing Partner Development Practice at Lean-Agile Partners

Minda Wilson

Founder, Affordable Healthcare Review

Keith Morel,Ph.D.

VP, Regulatory Compliance, Qserve Group US Inc.

Roy Wallen

President & CEO, Directional Healthcare Advisors, LLC

Steven Grossman

President, HPS Group, LLC

James Edward Ledlum, Jr

Director Corporate Supplier Quality, Hologic, Inc

Christine Santagate, RAC

Director, Boston Operations

Scott Phillips

President Starfish Medicals

Fletcher Wilson

CEO and Founder, InterVene Inc

Patrick Rousche

Co-Founder and Chief Scientific Officer, Hemotek Medical, Inc

Roni Cohen

Director of the Microbiology & Chemistry Division, HYLabs

Nancy Knettell

Principal, Signet Medical Systems

Susan W. Neadle

Sr. Director, Janssen Pharmaceuticals

Rick Williams

Partner, Newport Board Group New England Practice, Chairman of Point Care Technology, Board member of Amorphex Therapeutics

Mitch Levinson

Founder, President & CEO, Cerebrotech Medical Systems

Gunjan Sinha

Executive Chairman, MetricStream

French Caldwell

Chief Evangelist, MetricStream

Kevin Fleming

National Healthcare Managing Director, Newport Board Group

Julia Rasooly

Founder and CEO, PuraCath Medical Inc

Andrew Pfeifer

Account Executive, REED TECH

Haley Lentz

GUDID Submission Subject Matter Expert, Reed Tech

Angela Bazigos

CEO, Touchstone Technologies Inc

Jon Speer

Founder and VP of QA/RA,

Joe Franchetti

FDA Regulatory Compliance Specialist, JAF Consulting Inc

Eduardo Cervantes

President & CEO, Morf Media Inc
Robin Newman Director, Office of Compliance, Center for Devices and Radiological Health, FDA

Robin Newman is the Director for the Office of Compliance at FDA's Center for Devices and Radiological Health. Dr. Newman has 25+ years of senior level clinical/regulatory and compliance management experience in new product research and development. She's served as a senior level executive and consultant for regulatory strategy, clinical trial design and execution, standards and SOP development, quality system management and compliance, medical and technical writing, customer/patient interface and education, and management of Data Safety Monitoring Boards. Prior to joining FDA, Dr. Newman served as the Vice President of Quality Management for Siemens Healthcare Diagnostics, where she managed a multidisciplinary quality management and regulatory team and functioned as the primary representative for AdvaMedDx and the Diagnostic Tests Working Group. She holds a B.S. and M.S. in Nursing from the University of Texas, an Ed.D. from The George Washington University's Executive Leadership Program, and holds certifications as a Pediatric Nurse Practitioner, in regulatory affairs (RAPS), and as a CCRA (ACRP).

Adam Saltman, MD PhD Medical Officer, CDRH/Office of Compliance

Adam E Saltman MD PhD is a Medical Officer in the Office of Compliance, Center for Devices and Radiological Health, at the Food and Drug Administration. He has worked with the FDA in both the premarket and postmarket arenas as a clinical reviewer since 2008. His primary responsibilities there now focus on the compliance medical device removal and correction process, as well as incorporating clinical benefit risk evaluations in recall and potential recall situations. Dr. Saltman consults regularly on clinical risk evaluations, device recall classifications, and public-facing FDA and manufacturer communications. Dr. Saltman left his clinical practice in cardiothoracic surgery in 2016, during which he held a special interest and key opinion leadership in the surgical treatment of atrial fibrillation. He has published more than 100 peer-reviewed articles, served on several journal editorial boards, and conducted competitively funded research projects. Dr. Saltman also holds an appointment of Clinical Associate Professor of Surgery at the Ohio University Heritage College of Osteopathic Medicine, where he teaches residents and medical students. He received his MD and his PhD degrees from Columbia University, his MS in health informatics from the University of Illinois at Chicago, and is certified as a Quality Improvement Associate by the American Society for Quality.

Anupama V. Govindarajan, Ph.D. Medical Device Recall Branch Chief, FDA

Dr. Anupama Govindarajan is a Nanotechnologist-Engineer and Regulator with a passion for enabling the translation of medical devices from proof-of-concept to safe clinical use – particularly for patients with unmet needs. She received her Ph.D. in Electrical Engineering from the University of Washington in Seattle in the area of micro and nano technologies for biomedical implants.

Her work experiences in the medical-device field over the last fifteen years have been enriched by closely participating in the diverse viewpoints of different stakeholders across many cultures: large companies like Lockheed Martin, startups, academia, research institutions with vast budgets (A*STAR Singapore), and funding organizations & non-profits. In these positions, she has held several technical-leadership positions in the development of miniaturized active implantable devices, paper microfluidics and point-of-care diagnostics for resource-limited settings.

In her recent role as a lead reviewer in The Division of Neurological and Physical Medicine Devices (DNPMD) in the US Food and Drug Administration (FDA), she has often led the review of several complex and novel first-in-human medical devices involving management of interdisciplinary review teams across the FDA. Her experiences have focused heavily on device design, stimulation safety, clinical trials and regulation of Neurostimulation devices. In 2016, she detailed as Senior Policy Advisor with CDRH Innovation (Office of Center Director). CDRH Innovation’s mission is to enhance patient access to innovative and critical medical devices. Toward this mission, she helped craft regulatory support strategies promoting early-feasibility and first-in-human studies for pediatrics, NIH SBIR programs, micro- and nano- technologies in medicine, and for philanthropic-award grantees developing translational medical devices.

Dr. Govindarajan serves on the FDA’s Nanotechnology Task Force Standards sub-committee & the CDRH Pediatric extrapolation for devices (PEDs) team. She co-founded the Neuromodulation Discussion Group at CDRH/FDA. Having worked in medical device development and regulation internationally – across industry, academia and government, she understands the crying need for patient safety and investigations of recalls in the field. She looks forward to her new role as Recall Branch Chief and hopes to take on leadership roles in the development of a reliable global medical-device ecosystem.

Ronny Brown Branch Chief for Medical Device Recalls, FDA

Stephen Allan Weitzman Editor in Chief, FDA Information Repository, IRAI

Stephen Weitzman has been involved in healthcare matters for the past 45 years as a practicing lawyer and science consultant in the pharmaceutical, medical device, and food industries. He is a pioneer of the use of computers in legal and science research and litigations support systems from mainframe to personal computers. In the early 70’s he set up complex litigations support systems for fortune 100 corporations and their associations in the FTC nutrition advertising proceeding. Those systems blended data from exhibits, attorney files, science literature, surveys, and court decisions, including text and image files. He worked with Brower Murphy who created the first CD-ROM for data on a Toshiba music disc player, the Library of Congress Catalog as Library Corporation. Steve created the first CD-ROM on a government agency (FDA) in 1984, including internal FDA documents and manuals relating to training drug reviewers to enforcement manuals. He also built the FDA’s original website section on regulation enforcement.

In recent years he has also been involved in prosecuting major civil fraud litigation and patent infringement. The fraud litigation involved drug diversion and potential counterfeiting. The patent matters relate to information technology systems.

Currently focuses on the Medical Informatics for healthcare issues related to establishing a functional national health information infrastructure for sharing medical records for research, safety surveillance, and personalized medicine.

Casper E Uldriks Former Associate Center Director, FDA, CDRH

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.

Rita Hoffman RAC, Managing Partner, Regs & Recall Strategies, Former Branch Chief, Recalls, CDRH, FDA

Rita Hoffman, RAC. Managing Partner Regs & Recall Strategies, LLC .Ms. Hoffman has more than 36 years of FDA experience across the device, drug and veterinary industries. She has an intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. As an FDA compliance consultant, she provides clients with regulatory insight, advises on critical compliance deficiencies, performs compliance and new product audits, provides insight and guidance on recall strategies to the medical device industry, and advises on jurisdiction determinations for combination products.

Ms. Hoffman retired from the FDA in January 2011 as the Recall Branch Chief for the Center for Devices and Radiological Health (CDRH), where she was responsible for oversight and review for all medical device recalls. Ms. Hoffman held several positions including the Center for Drug Evaluation and Research (CDER) Jurisdiction Review Officer (providing guidance on drug/device product designation, combination products and co-packaging), Acting Associate Ombudsman, Small Business Liaison, and was a Policy Analyst for eight years in the Office of the Commissioner. She served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, and in 2008 was presented with the Special Recognition Award by RAPS.

Daniel L. Aisen Quality Assurance. Regulatory Compliance, Proven Leadership, Former FDA Field Investigator and Former Public Health Inspector Naval Chief Hospital

Pat Baird Regulatory Head of Global Software Standards, Philips

Nick Sikorski Manager, Deloitte & Touche LLP

Nick is the Global Program and Solutions Leader for Deloitte & Touche’s Medical Device Safety and Security (MeDSS) practice, which focuses on securing connected medical devices and other life sciences products. He primarily works with Medical Device Manufacturers and Healthcare Providers designing, developing, and implementing enterprise level Medical Device Security Programs. Nick also works at a device level defining security requirements, developing product security risk assessment frameworks, and conducting product security risk assessments. Beyond consulting, Nick is active across the life sciences industry through his work on AAMI’s medical device security work group and through conference presentations and panels.

Roy Wallen President & CEO, Directional Healthcare Advisors, LLC

Roy Wallen leads Directional Healthcare Advisors, LLC as its CEO. He has served in leadership roles for new product initiatives for more than 25 years in medical technology companies ranging from pre-revenue start-up to multi-billion, global concerns. With an undergraduate degree in electrical engineering and a biomedical focus, as well as graduate studies in biomedical engineering and business, Roy has spent his career managing existing businesses for sustainable profits and bringing new technologies out of the laboratory and into clinical use. He has led successful commercial launches of new healthcare technologies in the United States, Europe, and Asia. Roy has published 13 peer-reviewed papers and 20 abstracts and short papers related to healthcare technology and its implementation.

Stan Mastrangelo Technical Committee Member of working group on ISO 31000, ISO 14971, and ICH Q9 Standards, Professor, Center for Applied Health Sciences, Virginia Tech University

Stan Mastrangelo has over 30 years of professional work experience in Quality Assurance of medical devices, pharmaceuticals, and foods. Stan has held positions such as Senior Quality Engineer, Corporate Quality Assurance Auditor, Plant QA Manager, QA Director, and Consultant. Stan was a member of the ANSI Executive Standards Board. Stan has had extensive involvement in the development of International Risk Management Standards. Stan was a member of the ISO Joint Working Group for Risk Management of Medical Devices (that developed ISO/IEC14971). Stan was a committee liaison to the ISO Technical Management Board Joint Working Group on Risk Management that developed ISO 31000 which is the Risk Management Standard for all sectors. Stan was on the US PhRMA (Pharmaceutical Research and Manufacturers Association) Team that supported the development of ICH (International Conference for Harmonization) Standard Q9 titled Quality Risk Management for Pharmaceuticals. Stan also served on various IEC Standards Teams related to IEC 60601, IEC 80001 and Risk Management in the Software Lifecycle. Stan is an Adjunct Professor at Virginia Tech and was a co-developer of a Masters Degree Program in Medical Product Risk Management. Stan is on the Risk Management Committee for the IECEE.

Peter Pitts Chief Regulatory Officer, Adherent Health, LLC.

Peter Pitts is President of the Center for Medicine in the Public Interest. A former member of the United States Senior Executive Service, Peter was FDA's Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency's obesity working group and counterfeit drug taskforce and is a Special Government Employee (SGE) consultant to the FDA's Risk Communications Advisory Committee.

Specific areas of global policy expertise include FDA policy and process, healthcare technology assessment and reimbursement issues, biosimilar development, Rx-to-OTC switching, risk management plans, GMP policies, pharmacy education programs, drug safety, DTC/ItP, Critical Path, personalized medicine, clinical trial transparency, IP protection, FDA reform, drug importation, counterfeiting, genetically modified food issues, food safety and security, recalls, nutritional labeling.

In 2010, he was named by Modern Healthcare magazine as one of the 300 most powerful people in American healthcare.”

His comments and commentaries on health care policy issues regularly appear in The New York Times, The Los Angeles Times, The Washington Post, The Wall Street Journal, The Financial Times, Health Affairs, The Boston Globe, The Washington Times, The Chicago Tribune, The Chicago Sun Times, The San Francisco Examiner, Investor's Business Daily, The Baltimore Sun, The Economist, Nature Biotechnology, The Journal of Life Sciences the BBC World Service, Fox News, and The NewsHour with Jim Lehrer, among others.

Steven Grossman President, HPS Group, LLC

Steven Grossman is President of HPS Group, LLC, a consultancy that provides strategic counsel, analysis and advocacy on regulatory and policy issues involving the U.S. Food and Drug Administration. Mr. Grossman serves on the Board of Directors of the National Organization for Rare Disorders (NORD) and sits on the board’s executive committee. He is also a founder and deputy executive director of the Alliance for a Stronger FDA, a multi-stakeholder coalition that advocates for increased resources for the FDA. Earlier in his career, Mr. Grossman was Deputy Assistant Secretary for Health at HHS and Health Staff Director and Counsel to the Senate HELP Committee.

Brian Shoemaker Ph.D., Principal Consultant, ShoeBar Associates

Brian Shoemaker provides consulting services and training in computer system validation, software quality assurance methodology, and electronic records and signatures. His projects have included validating process-equipment software, validating embedded medical-device software, developing software quality systems, assisting companies through regulatory-compliance projects, and evaluating systems for 21 CFR Part 11 compliance. His clients have included firms in the medical-device fabrics manufacturing, plastics molding, contract lyophilization, outsourced medical device engineering, clinical trial software development, dental prosthetics, and bone-repair implant fields. He has worked with companies in Germany and Switzerland as well as the U.S.

Previous to founding ShoeBar Associates, Brian served as Quality Assurance Manager at PPD Informatics (now CSS Informatics), QA/Validation for Doxis, Inc., and Systems Engineering Manager at Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.

Virginia A. Lang, PhD President & Chief Scientist, HirLan, Inc.

Virginia started in the medical research field as a Coordinator of Research at the Clinical Research Unit Kennedy Institute of Johns Hopkins Medical Center. She was responsible for the initiation, coordination, and management and/or analysis of research projects in the Clinical Research Unit. These projects were funded by various Federal Government Agencies. Subsequent to Johns Hopkins Medical Center, Virginia entered the field of Human Factors through the doctoral program at SUNY Binghamton. Virginia held a fellowship at the Aeromedical Research Laboratory of the United States Air Force at Wright-Patterson AFB, Dayton, Ohio and a fellowship at NASA. Her research dealt with cognitive factors that differentially affect the characteristics of visual displays. Applications of this research are directly related to various medical devices and software applications providing Medical Device Human Factors by HirLan clients with 30 years of Human Factors experience.

In addition, Virginia has extensive experience in the areas of product design, Customer Centered Participatory Design processes, and product lifecycle management. She is also known in the Human Computer Interaction and Usability Communities for her innovative techniques for collecting and incorporating user/customer feedback throughout the product lifecycle. In July 2014, Virginia founded and established the HirLan Institute of Human Factors with labs in Carlsbad, California and a Consortium arrangement in London, UK. In February 2013, Virginia founded HirLan International SA, a Geneva, Switzerland based company. Both HirLan and HirLan International have been supporting Top Ten pharma/medical device companies, as well as, start-ups with consulting and testing services. These services are in conjunction with their clients' FDA 510(k) and CE mark applications.

Virginia holds a PhD in Cognitive-Experimental Psychology from SUNY Binghamton, and a Master of Science (ABT) in Applied Technology, Systems Science from SUNY Binghamton.

Kwame Ulmer Medical Device Executive | Angel Investor, Principal, Ulmer Ventures

Kwame Ulmer is a MedTech executive with nearly twenty years of experience in government and the private sector. He is currently an Angel Investor and regulatory strategy consultant with a focus on MedTech and Venture Capital firms. Mr. Ulmer previously served as Vice President, Regulatory Affairs and Quality Assurance at Implant Direct, a Danaher Corporation Operating Company. He led efforts to shorten global registration timelines, improved product quality by process optimization and achieve best-in-class department engagement scores. Kwame has served in progressive leadership roles at the US Food and Drug Administration (FDA) where he ran operations of a seventy four - person division. Kwame has personally evaluated over 1,000 medical technologies.

Roni Cohen Director of the Microbiology & Chemistry Division, HYLabs

Mike Colvin Medical Device Consultant/Advisor, Syntilla Medical LLC

Mike has over 30 years’ experience developing medical devices and systems. Over his career he has been in charge of safety & efficacy testing and Regulatory & Clinical strategies. He has also served as a technical advisor/consultant in the medical device industry for over 25 years, giving him exposure to both large medical device companies and startups.

Mike has taught college for over 25 years and has contributed/participated on many domestic and international technical committees. He holds a Ph.D. in Physical Chemistry from the University of Southern California/California Institute of Technology.

James Barley President, Ambired Consulting Services

James Barley is a founder of Abrimed Consulting Services, a Medical Device Regulatory Affairs and Quality Assurance Consulting company. Mr. Barley graduated from Lowell Technological Institute with a degree in Engineering and later earned his Masters of Business Administration from Pepperdine University. During the last 20 plus years, Mr. Barley has been consulting for small and medium sized medical device companies. These services included setting up quality systems compliant with the FDA’s Quality System Regulation, ISO 9001 and ISO 13485.

In addition, Mr. Barley has prepared 510(k) submissions for instruments, disposables, electronic equipment and software as well as Technical Files for Class Im, 1s, IIa and IIb. Since the FDA has begun enforcing its Refuse To Accept Policy, Mr. Barley has successfully navigated through the requirements of the FDA Policy.

Larry Stevens Principal Consultant (Ex FDA), One Way Consultants, LLC, FDA Regulatory Experts

Larry is a professional speaker who can train persons on all aspects of FDA requirements, and practical and successful solutions to FDA problems. He has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems; prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public.

Scott Phillips President, Starfish Medicals

Scott holds a degree in Engineering Physics from the University of British Columbia. Prior to starting StarFish, he worked in diverse areas such as lithium battery development and manufacturing, UV spectroscopy instrumentation and hi-fi audio speakers. Under his leadership StarFish has grown from being a highly motivated team working on one project at a time to a diverse professional organization with clients around the world and 100% focus on medical devices.

Darin S. Oppenheimer, DRSc, FRAPS, RAC, PMP Executive Director, Regulatory Devices & Digital Health Solutions, Merck

James Edward Ledlum, Jr. Director Corporate Supplier Quality, Hologic, Inc

SSA Steven T. Sciavolino Mission Critical Engagement Unit , Cyber Division, FBI

Christine Santagate, RAC Director, Boston Operations

Dan O'Leary President at Ombu Enterprises, LLC

Is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Nancy Knettell Principal, Signet Medical Systems

Nancy Knettell has over 30 years in combined Mechanical Design, Software Development, and Systems Engineering experience primarily in the Medical Device industry as a Software Verification Validation/Systems Engineer.

Along with her Senior Level Management experience with cross-functional Program Teams for such companies as EMC and United Technologies, Nancy has also consulted to major medical companies such as Smith and Nephew, Philips Medical, CR Bard, Kollsman Medical, Applied Biosystems, Deka Research, Avedro and Hologic.

But, for Nancy, involvement in medical device development is a personal issue. Having lost her father at an early age to heart disease, she now wants to work to help other people facing such life threatening events. It is her mission to advance the potential for life-saving medical devices through the use of quality based engineering systems.

Nancy's team at Signet can help you implement a Software Quality System rapidly and to full compliance with both current US and European ISO 62304 FDA Software Validation Requirements.

Signet can also help your company prevent costly errors due to inexperience developing software for medical devices by leveraging her company's extensive software systems development know-how and comprehensive design and documentation resources ready for your immediate implementation.

Nancy hold a Bachelors of Science in Information Technology from UMASS Lowell (graduated magna cum laude.) She is also an inducted member of Phi Beta Kappa National Honor Society. Nancy, along with her husband, are avid horse sport enthusiasts.

Nancy Van Schooenderwoert President, and Managing Partner Development Practice at Lean-Agile Partners

Tim Henning Co-Host of, HealthReform 2.0 Show and Podcast

Tim has over 37 years of experience in medical industry both in the Unites States and International markets.

Tim spent over 30 Years in the Medical Device Industry, with focus on Diagnostic Imaging, Radiation Oncology, Women’s Health, Surgical Robotics and the Treatment of Vertebral Pathologies.

Tim served in many senior executive positions, including Sr. VP for Global Operations with ADAC Laboratories from 1988 – 2004, the first medical device company to win the prestigious Malcolm Baldridge National Quality Award.

Tim then joined a large Imaging, Radiation Oncology and Women’s Health Provider, providing Serviecs to Hospitals, Physicians and Patients across 23 States where he served as Sr. VP and General Manager.

Tim has extensive background in medical imaging and radiation oncology, both from sales and also the provider side. He is a graduate of Parkland College with a degree in Electrical Engineering.

Robert Mai Senior Manager, Deloitte & Touche LLP

Robert is a Cyber Risk senior manager and has over 15 years of experience with information technology, regulatory compliance, and business process & technology controls across various industries. He has served his clients in a wide range of cyber risk roles which included: security, privacy, and compliance assessments; developing cyber strategies / roadmaps / programs based on leading industry requirements (HIPAA, NIST, ISO, PCI, SOX, etc.); backfilling for strategic security roles within organizations; and leading security work streams on large scale, multi-million dollar business transformation efforts and enterprise resource planning technology implementations.

Robert is also a portfolio leader for Deloitte’s Medical Device Safety and Security (MeDSS) practice. In this role, he focuses on helping life science and healthcare clients address security of medical devices throughout their product lifecycle.

Robert received a Bachelor of Arts degree in Economics from the University of California, Los Angeles. In addition, he holds numerous certifications including the Certified Information Systems Security Professional (CISSP), Certified Information Systems Auditor (CISA), and Certified Cloud Security Professional (CCSP).

Martyn Gross CEO, Skylit Medical

Daphne Walmer Thought Leader/Expert/Consultant in Medical Device Labeling and Technical Communications

Daphne Walmer is a former Director of Technical Communications at Medtronic who pioneered the use of electronic manuals in the medical device industry. Her group obtained approval to test eIFUs in the European Union for 10 years before their approval in 2013. She helped review the EU regulation for the industry, and led the effort for Medtronic to comply with its requirements. She currently consults in the areas of management of user documentation, translation and localization, and component content management systems.

Fletcher Wilson CEO and Founder, InterVene Inc

Fletcher Wilson is the Founder and CEO of InterVene, Inc., a start-up medical device company working in the peripheral venous space. Fletcher raised a Series A with subsequent closings from an investor base of over 60, including a corporate strategic, two venture capital firms, three angel groups, and various individuals. He is the first named inventor on two issued patents, and numerous active applications in the interventional venous space. Prior to InterVene, Fletcher was a Stanford Biodesign Fellow, where he and his teammates identified the clinical need and initial solution that would become InterVene. Prior to Biodesign, Fletcher was an R&D engineer at a two person device start up, InSite Medical, and an R&D intern at Boston Scientific. Fletcher received his Master's degree in Mechanical Engineering from Stanford University and his Bachelor's Degree in Mechanical Engineering from the University of Pennsylvania.

Marisa White Lead Consumer Safety Officer, Division of Bioresearch Monitoring, Office of Compliance, CDRH

Marisa White is the Regulatory Misconduct & Complaints Lead CSO for the Division of Bioresearch Monitoring (DBM) in the Office of Compliance at FDA's Center for Devices and Radiological Health (CDRH). Marisa started at the FDA in the International Operations Branch under the Office of Regulatory Affairs (ORA), where she was involved in the coordination of FDA foreign inspections as the Bioresearch Monitoring (BIMO) Program Team Lead. Prior to FDA, Marisa worked at the New York Blood Center as a Research Assistant before becoming a Clinical Research Program Coordinator at Johns Hopkins University in the Oncology Department, where she managed data and regulatory requirements for various multi-center protocols, with coordinating center responsibilities. Marisa also served as a Sr. Research Program Coordinator for the Leukemia Research Group with responsibilities for training and SOP writing/updates. After Hopkins, she held several roles at a clinical research organization (Covance, Inc.), one of which was a Clinical Research Associate (CRA) involved the set-up and monitoring of clinical trials. Marisa holds a BS in Biotechnology & minor in Biochemistry from Rutgers University and a CCRP certification from SoCRA.

Seth D. Carmody,Ph.D Cybersecurity Project Manager, CDRH

Dr. Carmody is currently working as the Cybersecurity Project Manager in the Office of the Center Director, Emergency Preparedness/Operations & Medical Countermeasures. Seth also serves as a subject matter and policy expert with CDRH's Cybersecurity Working Group.

Seth joined the FDA's Center for Devices and Radiological Health in 2011 as a medical device reviewer in the Division of Chemistry and Toxicology Devices where his duties focused on premarket approval of diabetes-centric devices and software recalls.

Bakul Patel Associate Director for Digital Health, FDA

BAKUL PATEL is Associate Director for Digital Health, at the Center for Devices and Radiological Health (CDRH), at the Food and Drug Administration (FDA). Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, health information technology, cyber security, medical device interoperability, and medical device software.

Mr. Patel is the FDA liaison between the Federal Communications Commission (FCC) and the Office of the National Coordinator (ONC). Since its inception in 2013, Bakul chairs the International Medical Device Regulators Forum (IMDRF) “software as a medical device” working group, a global harmonization effort.

Before joining FDA, Mr. Patel held key leadership positions working in the telecommunications industry, semiconductor capital equipment industry, wireless industry and information technology industry. His experience includes Lean Six Sigma, creating long and short-term strategy, influencing organizational change, modernizing government systems, and delivering high technology products and services in fast-paced, technology-intensive organizations.

Mr. Patel earned an MS in Electronic Systems Engineering from the University of Regina, Canada, and an MBA in International Business from The Johns Hopkins University

Chrissy Cochran Acting Director, Division of Enforcement and Postmarketing Safety, FDA

Bill MacFarland Director, Division of Enforcement B, Office of Compliance, FDA/CDRH

William MacFarland is the director of the Division of Enforcement B within the Office of Compliance. In this position, he is responsible for overseeing the division's 33 member review staff who review PMA Manufacturing Sections, Establishment Inspection Reports, recall classifications and compliance cases.Previously, Mr. MacFarland worked in CDRH's Office of Device Evaluation as both a reviewer and Deputy Division Director in the Division of Cardiovascular Devices. Prior to his current work at FDA he was a consultant with Quintiles Consulting where he was responsible for providing clients with strategic regulatory guidance and managed their 510(k), PMA and IDE projects. Additionally, he developed medical product test strategies, provided review of non-clinical protocols and reports, and provides guidance on compliance with Design Controls throughout medical device development. Mr. MacFarland has also worked for Angiosonics, Inc. of Morrisville, NC as Director of Regulatory Affairs.

Mr. MacFarland received his MBA from University of Maryland in College Park, MD, and his MS in Biomedical Engineering from Case Western Reserve University in Cleveland, OH. He received his BS in Electrical Engineering from Clarkson University in Potsdam, NY. Currently he maintains a Professional Engineers license in Maryland and is an ASQ Certified Quality Engineer, Certified Biomedical Auditor, Certified Software Quality Engineer, Certified Six Sigma Black Belt, Certified Manager of Quality/Organizational Excellence and Certified Reliability Engineer.

Erin Keith Director, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, CDRH, FDA

Erin Keith is the Director for the Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices (DAGRID) in the Office of Device Evaluation (ODE) at the Center for Devices and Radiological Health (CDRH). As the DAGRID Director, Ms. Keith provides executive oversight of the division’s premarket programs and review policy for a wide-range of medical device product lines; establishes the division strategic priorities; and supervises a diverse staff of medical, engineering and scientific staff. In her management role in DAGRID, she oversees DAGRID’s implementation of a unique risk-management pilot program, the Safety Assurance Case for Infusion Pumps. She also continues to teach on risk management topics, and represents CDRH in international standards development and harmonization activities.

Prior to her current position with DAGRID, Ms. Keith was the Deputy Director for Science and Policy for the Division of Orthopedic Devices (DOD) in ODE from May 2011 to November 2013. In DOD she provided oversight of the division implementation of review policy and scientific review issues. Additionally, Ms. Keith was the Assistant Country Director for Medical Devices at the US FDA New Delhi Office from February 2009 until May 2011. As an Assistant Country Director, Ms. Keith was responsible for analyzing the Indian medical device industry’s capabilities for meeting US regulatory requirements and developing a program to increase the Indian industry’s knowledge of US medical device regulatory requirements.

Cisco Vicenty Acting-Branch Chief, Office of Compliance, CDRH/FDA

Neil Mafnas, LCDR, USPHS, M.S. Assistant Regulator, CDRH/FDA

Lieutenant Commander Neil A. Mafnas is a Regulatory Officer in the United States Public Health Service Commissioned Corps. He is currently assigned to the Medical Device Single Audit Program (MDSAP) Team in FDA's Center for Devices and Radiological Health, Division of International Compliance Operations. As a member of the MDSAP Team, LCDR Mafnas's duties include the creation/development of policy, procedures, training and conducting outreach. Additionally, Neil serves as a Subject Matter Expert and Project Manager for the development/implementation of MDSAP's IT Portal. Neil began his career with the FDA in 2010 as a Consumer Safety Officer (CSO) in the Office of Compliance at the Center for Devices and Radiological Health. As a CSO in the General Hospital Devices Branch, he worked on medical device inspection classifications, recall classifications, medical device complaints and Consent Decrees for Permanent Injunction. Neil also works closely with the Association for the Advancement of Medical Instrumentation as one of the Agency's Quality System Regulation instructors. LCDR Mafnas has been in the Public Health Service since November 2011. Prior to coming to the FDA, he worked as the Safety Manager for a logistics firm. Neil also served in the United States Air Force as an active duty Space and Missile Maintenance Officer from 2001 to 2007. LCDR Mafnas holds a Bachelor's Degree in Biology from the University of Texas at Arlington, and a Master's of Science in Health Sciences from the University of Central Florida.

Ann Ferriter Director, Division of Analysis and Program Operations, CDRH/OC, FDA

James Saviola Deputy Director of Regulatory Affairs (Acting), and Director, Division of Biomedical Research, Office of Compliance, CDRH

Dr. James Saviola joined the Center for Devices and Radiological Health (CDRH) in 1986. He is a Captain in the U.S. Public Health Service and holds consulting staff credentials with the Optometry department at the Walter Reed National Military Medical Center, Bethesda, MD. Jim was a branch chief in the Office of Device Evaluation involved with ophthalmic devices from 1991 until January 2008. He then served three years in the Center Director's Office where he was responsible for helping to promote information exchange within CDRH to better identify and analyze medical device risks and develop public health responses. Jim has been with the Division of Bioresearch Monitoring in the Office of Compliance since January 2011. He's been serving as the BIMO Director since the fall of 2011. Under his direction the division has focusing on developing expertise in various program areas and expanding support of Class II medical device clinical study activities.

French Caldwell Chief Evangelist, MetricStream

One of the foremost thought leaders in IT, French Caldwell has been decisively shaping the GRC market for the last 12 years.

French is a former Fellow and Vice President at Gartner where he led their GRC research, including the influential Gartner Magic Quadrant on GRC, as well as research into disruptive technology. He also worked with the White House and U.S. Naval War College in 2002 to develop the Digital Pearl Harbor war game, the first ever strategic assessment of cyber war strategies. In 2012, the game took on a very real form with the strategic attacks on oil and gas infrastructure in Saudi Arabia and Qatar. French is also a retired naval officer and a nuclear submariner. Post-retirement, French served as a diplomatic liaison to NATO for the post-Cold War Congressional Commission on Roles and Missions of the Armed Forces.

As an academic, French served as a Federal Executive Fellow at the Brookings Institution, an Adjunct Fellow at the Center for Strategic and International Studies, and an Adjunct Professor and Graduate Research Advisor at the George Washington University School of Engineering Management. He has written a book on international law, and has over 400 published research papers.

French has a PhD in Law and Policy, an MA in International Economics, Strategy and Diplomacy, and a BS in Oceanography.

Minda Wilson Founder, Affordable Healthcare Review

Minda Wilson, J.D., is an author, entrepreneur, and a corporate attorney, specializing in healthcare. A recognized expert on the Patient Protection and Affordable Care Act, she consults with clients regarding its proper implementation. She is founder of Affordable Healthcare Review, an educational organization providing information about healthcare legislation, its application, and impact. For more than 20 years, Wilson has worked with companies in the areas of productivity improvement, crisis management, corporate organization, business and financial planning, and fraud detection.

Geetha Rao CEO, Springborne Lifesciences

Andrew Pfeifer Account Executive, REED TECH

Andrew works closely with a team of Subject Matter Experts at Reed Tech to provide submission solutions based on industry needs. Areas of expertise include coordinating with leaders spanning multiple business units in managing complex data submissions to the FDA as well as advising on best practices regarding recent UDI mandates. Additionally, he maintains high levels of Structured Product Labeling and XML conversion practices as well as downstream application and concerns of XML-driven data.

Angela Bazigos CEO, Touchstone Technologies Inc

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include Chief Compliance Officer,, QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA Patent on speeding up software compliance . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom . Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences:

Dr. Ron Weissman Chairman, Software SIG, Band of Angels

Dr. Ron Weissman was vice president of strategy and corporate marketing for Verity, a global leader in corporate information retrieval and knowledge management. During his tenure at Verity, the executive team earned the large company "turnaround of the year" award (1999) from the Turnaround Management Association; Verity gained dominant market share and saw its market capitalization grow from $50 million to more than $1.5 billion. Prior to Verity, Ron spent more than five years at NeXT Computer, where he managed European and corporate marketing. In addition to his work in Silicon Valley, he ran academic computing at Brown University and at the University of Maryland, where he was Associate Professor of History. He is the author of two books on the history of Florence during the Renaissance.

Terri Jollymour Sr. Director, Operations Readiness & Convergence Johnson & Johnson

Terri Jollymour is a member of the Operations Readiness & Convergence (ORC) enterprise group, leading strategic efforts in the convergent space for Johnson & Johnson (J&J). Terri works across the three main business sectors: Consumer/McNeil, Janssen Pharmaceuticals, and Medical Device & Diagnostics to ensure safety, quality and sustainability for the convergent space.

Within J&J's Convergent Space, Terri is responsible for comprehensive engagement with project teams to assess and mitigate new product development for product, process and program risks. This spans across early to late development and pre-launch readiness. Terri is also accountable for strategic leadership initiatives in the Supply Chain organization, such as leading the implementation of the Combination Product CGMPs. Terri's group is responsible for ad hoc support for convergent programs, to address specific issues or fill in specific roles on teams. Her group is also responsible for rapid tactical reponse for supply chain and/or quality and compliance mitigation issues across the enterprise. Terri leads the Convergent Network at J&J, which brings all three business sectors together for learning, sharing/leveraging and networking within this innovative space.

For over a decade, Terri has held top leadership roles in the convergent space within J&J. She has been responsible for leading large, complex, convergent product development program teams within J&J's pharmaceutical and medical device & diagnostic sectors. She has been recognized for her outstanding leadership with numerous company recognition awards and executive programs.

Terri earned her degree in Pharmacology at the University of California, Santa Barbara. Prior to J&J, she worked in the diagnostic space at Syva and led controlled release drug-delivery programs (combination products) at ALZA Corporation. She held positions of increasing responsiblities within program management, R&D, analytical sciences and quality assurance over her many years in the health care industry. She is a member of the Healthcare Businesswomen's Association and is a certified Project Management Professional. Terri is married and has three children and three dogs! She enjoys swimming with her masters team, cycling, hiking and skiing. She resides in Northern California.

Haley Lentz (GUDID Submission Subject Matter Expert, Reed Tech)

Haley Lentz is the Account Executive for the Life Sciences Division at Reed Tech. She is responsible for providing a GUDID submission strategy for medical device manufacturers based on a consultative, needs-based assessment.

Haley works closely with a team of Subject Matter Experts at Reed Tech to provide submission solutions based on industry needs. Areas of expertise include coordinating with regulatory affairs leaders in managing complex data submissions to FDA as well as advising on best practices regarding recent UDI mandates. Additionally, she maintains high levels of Structured Product Labeling and XML conversion practices as well as downstream application and concerns of XML-driven data.

During her time at Reed Tech, Haley has collaborated to publish two articles on UDI implementation,"US UDI/GUDID Submission Deadlines: What Medical Device Manufacturers Need to Know" and "Six Recommendations Regarding Upcoming UDI Compliance Dates".

Mitch Levinson Founder, President & CEO, Cerebrotech Medical Systems

Mr. Levinson is a start-up medical device executive with over 30 years of experience developing and bringing revolutionary new products to market. Mr. Levinson started Cerebrotech Medical Systems in 2011 based on a technology developed at UC Berkeley with the goal of improving care for brain injury patients with a noninvasive monitor to detect early stages of cerebral edema and bleeding. Mr. Levinson was the start-up President and CEO for Zeltiq Aesthetics, brought in by the investors, Frazier Healthcare Ventures and Advanced Technology Ventures, as the company's first employee. Zeltiq's groundbreaking cooling technology was licensed from Massachusetts General Hospital for non-invasive fat layer reduction. Mr. Levinson built the company from the ground up and launched the product 3 years later, in what has become widely regarded as one of the most successful medical device launches in the aesthetic space. Zeltiq has quickly become the world's premier fat layer reduction technology and is found in thousands of physician offices in the US and around the world. Zeltiq held its IPO in October of 2011 and by 2014 exceeded a market cap of $1 billion. Prior to Zeltiq, Mr. Levinson was the first technical employee at Thermage, where he led the product development as its founding Vice President of Research and Development. Thermage utilizes a radiofrequency-based technology and was the first device to provide non-invasive skin tightening. That company held its IPO in 2006, and has become a mainstay in aesthetic dermatology and cosmetic surgery physician practices. It is now part of Valeant Pharmaceuticals. Mr. Levinson was also the founding Vice President of R&D at BioSurgical Corporation, developer of a novel applicator for fibrin sealant, acquired in 2000 by Baxter International. Mr. Levinson has served as a product development executive at Nellcor (patient monitoring), Baxter (in vitro diagnostics), and as an engineer at ALCOA Intercon-X, and Hewlett Packard. Many of Mr. Levinson's innovations are represented in his 37 issued U.S. patents with more pending. He earned his B.S. in Engineering Sciences from University of California at San Diego and also holds a MS in Computer Systems from University of Phoenix.

Mark Mitchell SVP Corporate Development, MetricStream & Business Head ComplianceOnline

Mark has over 25 years of experience in enterprise software, corporate and business development, and mergers and acquisitions in various Silicon Valley technology companies. He played a key role in building valuable technology businesses in the US and globally, in several C-level roles. He was a co-founder at eMeter, a leading smart-grid company acquired by Siemens AG. He also held key operating executive and corporate and business development leadership roles at Serious Energy, Intematix, Scayl, and

Most recently, Mark was SVP Business Development at RiverMeadow, a leading provider of SaaS solutions for migration of servers into the Cloud. Mark's experience spans a range of businesses, including Fortune 500 and Global 1000 customers in the Americas, EMEA, and APAC. He is also a named inventor on three patents.

Mark holds a Master's degree in Business from Stanford University's Graduate School of Business, a Juris Doctorate from the University of California, Hastings College of the Law, and a Bachelor's degree in Computer Science from University of the Pacific.

Kevin Fleming National Healthcare Managing Director, Newport Board Group

Kevin has over 30 years of senior executive experience in the Health Care, Financial Services, Technology and Professional Services Industries in roles including CEO, President, COO, Managing Director and Senior Partner.

  • Newport Board Group - Partner 2013 - Current
    • Managing Director of Nationwide Healthcare & Life Sciences Consulting Practice with 29 professionals, most former CEO's. Overall firm has nearly 100 partners nationwide.
    • ePAY Healthcare - Acting CEO and Board Member (2013 - Current)
      • Nationwide Healthcare IT SAAS Company with operations in 42 states serving over 650 Hospitals, Ambulatory Surgical Centers and other providers.
      • Comprehensive Patient Responsibility Financial Management Platform to maximize patient revenue collections and introduce innovative lending and other financing options.
      • Responsible for all primary aspects of the company.
    • Leads/Directs M&A Buy and Sell, IPO, Capital Raising and other events.
    • Serves as a Board member for US Community Behavioral Health, a nationwide provider in Behavioral Health and Traumatic Brain Injury Post-Acute Care Rehabilitation.
    • Performs strategic Board and CEO level consulting and advisory projects for clients.
  • Paradigm Outcomes - CEO 2006 - 2012
    • Nationwide Catastrophic Injury and Chronic Pain management full service and risk taking Healthcare Accountable Care Organization (ACO)
    • Served also in progressive capacities as Board Director, President, CFO & COO
    • Orchestrated a highly successful turn around and monetization of the company.
  • Electronic Data Systems - Managing Director 2003-2006
    • Executive Leader for a very large strategic business unit serving the healthcare and financial services industries. Clients included Blue Shield, McKesson, UCSF Medical, HSBC, Visa and Citigroup.
    • Achieved significant top line and bottom line growth while securing key new logo revenue clients.
  • Ernst & Young - Senior Partner 1980 - 2000
    • Coordinating Partner for major accounts including Healthnet, Foundation Health, Bank of America, Wells Fargo and others. One of the youngest partners in the firms history.
    • Chairman and executive leader of a very successful nationwide M&A and post merger integration practice
  • Professional Groups - Bay Area Alliance of CEO's, Financial Executives Institute (FEI), AICPA & California CPA Societies.
Patrick Rousche Co-Founder and Chief Scientific Officer, Hemotek Medical, Inc

Eduardo Cervantes President & CEO, Morf Media Inc

Eduardo Cervantes is President and CEO of Morf Media, a leading compliance training system vendor which is enabling the Millennial, and subsequent generations to effectively train on compliance. Previously, Eduardo led several successful exits through M&A in the technology industry domestically and in Europe. He started his career in M&A with Goldman Sachs where he worked major consumer and pharma transactions. Eduardo holds an MBA and an MS from the University of Texas at Austin.

Tom Loker Businessman | Author | Speaker, Startup Consultant and Advisor SYDK.ORG, Contributor to California Political Review

Thomas Loker is a businessman, author, startup consultant and advisor. With almost 40 years’ experience in technology and healthcare, Tom is an established operations guy with serial successes with startups, transitional companies and turnaround situations. He has had a long career serving in the fields of science, technology and healthcare related industries. He is an active board member in both for-profit and not-for-profit companies. Tom has written numerous articles in the areas of healthcare, technology, politics and the economy. He maintains a passion for serving the underserved and has founded, supported and worked in various companies to serve the most fragile among us. When he is not working in business or writing Tom, is also an accomplished photographer. Prior to his latest book, The History and Evolution of Healthcare in America: The untold backstory of where we've been, where we are, and why healthcare needs more reform, Tom published “Delusional Ravings of a Lunatic Mind”—a collection of essays on healthcare, politics and their interaction with the economy, available at Amazon, Barnes and

Nobles, and other bookstores—and with his son Aleck, “Calistoga Ranch – A Photo Collection”—a photo essay of pictures from the Napa Valley area of California focused on Calistoga Ranch, available at Blurb.Com.

Susan W. Neadle Sr. Director, Janssen Pharmaceuticals

Susan W. Neadle is a member of Janssen's Global Product Quality Leadership and is a Design Excellence Black Belt. Her accountabilities span from leading Janssen's Combination Product Center of Excellence to creating new quality frameworks for emerging platforms and technologies, Design-to-Value, criticality analysis and risk management, and Quality Engineering for Janssen's portfolio of products.

Over her extensive career, Susan has played integral leadership roles in the product and process development of over a dozen new products. She was awarded the Johnson Medal, Johnson & Johnson's highest honor for innovation excellence, for invention and development of a product platform central to J&J Vision Care's portfolio. This technology was also awarded the "SILMO Award" for Innovation, Technology & Creativity in Europe, and the "Good Design Award" in Asia.

Susan's experience includes enabling and applying advanced product and process analytics to drive proactive process capability and product quality. She is a core-team member of the J&J Convergent Technologies Network. She has been recognized for her contributions in CTQ Flow-Down, DTV and PLM Initiatives, to drive improved robustness in product quality through the end-to-end lifecycle management.

Susan earned an M.S. in Polymer Science & Engineering, and a B.S. in Biology/Chemistry, and Fellowships in the American Academy of Optometry and the British Contact Lens Association. Prior to joining J&J, she held R&D, quality, and commercialization positions at Unilever, Organon Teknika, and IBM. In these positions she worked in controlled release technology, biomedical diagnostics, and materials analysis.

In addition to Susan's professional experience, she holds numerous patents, has written a variety of papers, and has frequently presented on topics related to her contributions to, and areas of subject matter expertise in, the medical device and pharmaceutical industries.

Gunjan Sinha Executive Chairman, MetricStream

Gunjan Sinha is responsible for leading MetricStream's overall strategy and execution. Gunjan currently serves on the Board of Directors of several Silicon Valley companies, and was appointed in 2010 to the Board of the US-India Science and Technology Research Endowment Fund by the US State Department to promote entrepreneurship and innovation. Additionally, he is the Chairman of which brings transformative healthcare education to under-served communities.

Over the course of his career, Gunjan has spent over 20 years in various entrepreneurial, board, and executive positions building innovative businesses. He was the Co-Founder and President of WhoWhere? Inc., a leading Internet directory services company that was acquired by Lycos in 1998, as well as eGain, an online customer service company which he built from inception to post NASDAQ IPO.

Gunjan obtained his BS and MS degrees in Computer Science from the Indian Institute of Technology, New Delhi, and UC Santa Cruz, respectively. He also holds an MS in Industrial Engineering and Engineering Management from Stanford University. Gunjan has been featured as one of the 50 most successful immigrant entrepreneurs in the US by Silicon India.

Julia Rasooly Founder and CEO, PuraCath Medical Inc

Ms. Rasooly is the Founder and CEO/ President of PuraCath Medical -- a medical device startup in home dialysis and was spun out of Stanford University during her graduate school education in 2012. Ms. Rasooly has over twelve years of experience in R&D in medical device and biotech industries. She is focused on revolutionizing the dialysis industry and bringing her novel home dialysis technology to make dialysis at home safer and more affordable. Prior to being the Founder and CEO of PuraCath Medical, she was a researcher at the renowned Molecular Imaging Laboratory at Stanford University School of Medicine, where she worked on stem cell therapy and imaging projects. Julia has obtained a B.Sc. in Bioengineering from the University of California Berkeley, an M.S. in Bioengineering from Stanford University, an M.S. in Medicine from Stanford University, and a Certificate from the Summer Institute for Entrepreneurship from the Stanford Graduate School of Business (GSB). She took a "“leave-of-absence" from her PhD program in Bioengineering from Stanford University to grow PuraCath on a full-time basis. She has won multiple honors and awards, including the Howard Hughes Medical Institute Medical Scholar, the National Ford Foundation Pre-Doctoral Fellowship, the National Coca-Cola Scholarship, and multiple other governmental grants and awards for start-up ventures. She also is the co-founder and President of two non-profits focused on tech entrepreneurship as well as women entrepreneurs in healthcare.

Joe Franchetti FDA Regulatory Compliance Specialist, JAF Consulting Inc

As JAF Consulting, Incorporated's Managing Consultant, Joe Franchetti is an industry leader and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation in regulated environments. For over 20 years, Joe has been involved with the development, purchase, installation, operation and maintenance of computerized systems used in all phases of drug development. In addition, Mr. Franchetti has over twenty five years of progressive experience in information technology and data management in the pharmaceutical and lie science industry.

He has extensive experience with all aspects of computer systems validation and compliance and is involved with the ACDM Clinical Research-CSV Working Party working on a chapter on GAP analysis, and has recently been involved with a chapter on Risk Assessment for the recently released DIA PEACH publication on Computerized Systems used in Clinical Trials and has also been involved with the GAMP Special interest Group on Laboratory Systems publication. Joe is currently the Training Chairperson for the Society of Quality Assurance's Computer Validation Initiative Committee.

Jon Speer Founder and VP of QA/RA,

Jon is the Co-founder & VP of QA/RA at, a software company that produces beautifully simple quality management software exclusively for medical device companies. He is also the founder of Creo Quality, a consultancy that specializes in assisting startup medical device companies with product development, quality systems, regulatory compliance & project management. Jon started his career in the medical device industry over 16 years ago as a product development engineer after receiving his BS in chemical engineering from Rose-Hulman Institute of Technology.

Rick Williams Partner, Newport Board Group New England Practice, Chairman of Point Care Technology, Board Member of Amorphex Therapeutics

As Chairman of the Board for an international medical device company,led successful strategic repositioning work in response to the evolving technology, market and financial environment. The repositioning involved a product transition from hardware to disposables.Lead funding initiatives with private and VC investors. Founded and led an award winning real estate development company. As Board Chair, led the transformation of a quasi-public state agency into a one stop center for small firms lacking access to conventional financing. Led large projects for public and private clients on the impact of regulation on major US industries. He as helped numerous companies and investors evaluate new business opportunities.

Board member of VC backed med tech company bringing slow release long term drug delivery product to market.

David Nettelton Industry Leader, Author, and Teacher for 21 CFR Part 11, Annex 11, HIPAA, Software Validation, and Computer System Validation

Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.

He has completed more than 230 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

Rohit Bedi Senior Vice President & Executive Leadership, MetricStream

As the SVP of Partnerships, Rohit is responsible for leading global partnerships by enabling the influence, distribution and delivery capabilities of our partners.
In a career that spans the full lifecycle of enterprise software, Rohit has been involved with building dominant software brands and successful companies in leadership roles. Most recently, Rohit led large company partnerships and strategic business in enterprise software at Cognizant. Prior to that, he was part of the executive team at Cymbal where he managed worldwide sales, marketing and partnerships leading to a successful acquisition. In the growing days of Seibel, he was responsible for an entire product line at Siebel Systems including expanding the partner network which played a big role in Siebel's distribution and delivery channel expansion. He was also in Product marketing roles at PeopleSoft.

Rohit is very passionate about coaching young juniors and has advised growing entrepreneurial firms in software and services. He has also helped institutions that support talented underprivileged children in golf. Rohit received his MBA from Harvard University, M.S. from the University of Alabama, and B.E. from Delhi College of Engineering, all with honors.

Vesna Janic Director of Quality/Regulatory, StarFish Medical and ViVitro Labs Inc.

Vesna Janic is a Director of Quality/Regulatory Department at StarFish Medical and ViVitro Labs. Her expertise is in regulatory compliance and conformance with standards, such as: cGMP, GLP, GCP, QSR, ISO 13485 and ISO 17025. Vesna is certified by the SQA as a Registered QA Professional in GLP, has Lead ISO 13485 Auditor certificate and holds a Bachelor of Science degree in Biology.

Vesna has 18 years of experience as part of Senior Management team and 10 years as SCC GLP inspector (volunteer position), and 8 years as QA/RA Director in medical devices field.

Prior to joining StarFish and Vivitro, Vesna worked for 6 years for CANTEST, life science company providing QA support to pharmaceutical division conducting GCP, GLP and GMP testing; 10 years with BC Research: in R&D – 6 years, followed by 4 years as a Quality Manager supporting GLP, GMP and ISO 17025 testing in chemistry and ecotoxicology departments.

Matt Matuszewski Director Operations, Johnson and Johnson

Matt Matuszewski is currently Director Marketed Combination Product Quality, in the Janssen Quality organization. In this role, he provides Quality Engineering leadership and oversight to collaborate with Supply Chain and other key stakeholders to ensure quality improvement opportunities for marketed Combination Products are identified, prioritized and executed in a manner that meets business needs. He is also responsible for the use of quality principles and tools, including process owner for Product Risk Management, outlining the end to end product risk management execution of the Janssen product portfolio.

Matt has over 30 years of cross-functional, cross-sector experience at Johnson & Johnson including Quality, Supply Chain and Research & Development leadership roles in Medical Devices, Pharmaceuticals, and Consumer Products.

Most recently, Matt drove Strategy and Execution, in the Janssen Supply Chain (JSC) organization, partnering to translate strategy to action, driving implementation of our customer-focused vision. In medical devices, he led the Design to Value (DTV) Strategy in Global Surgery R&D where he led cross functional teams to embed the principles of DTV into their New Product Development processes across the ten Global Surgery companies to improve the effectiveness of new product launches and product lifecycle management. Matt was also an R&D leader at Ethicon managing R&D for several electromechanical product teams. Prior to Ethicon, Matt was with Independence Technology, LLC. At this J&J startup, he was responsible for the Supply Chain and New Product Development functions working with external partners which led to the development, manufacture and launch of the innovative iBOT® Mobility System.

Before his role in Medical Devices, Matt was in the Pharmaceutical and Consumer sectors where he held roles of increasing responsibility in Supply Chain and Process Excellence. While with the Pharmaceuticals group, he led the Lean Manufacturing implementation and black belt project teams at our manufacturing plant in Gurabo. With the Consumer Products group, Matt held various Supply Chain roles, including Product Supply Lead where he led successful new product introductions for our Clean and Clear brand.

Matt has a B.S. in Mechanical Engineering from Rutgers University, and a M.S. in Management and an M.S. in Mechanical Engineering, both from the Massachusetts Institute of Technology.

Lifei Liu, PhD, RAC Associate Director, Regulatory Affairs at Abbott

Michael A Swit Principal, Law Offices of Michael A. Swit

Michael A. Swit focuses on solving the legal challenges confronted by the pharmaceutical, medical device, and other life sciences industries in tackling the myriad of legal mandates enforced by the U.S. Food & Drug Administration. Mr. Swit has extensive experience counseling life sciences firms on the demands of compliance with FDA's statutory and regulatory requirements to develop and market safe and effective drugs, biologics, medical devices, IVDs and other products. He also has advised regulated firms on a wide range of FDA regulatory matters, including drug and device approvals and marketing/promotional claims, dietary supplement health claims and regulatory issues in corporate acquisitions. His experience includes FDA development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts.

Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. Before joining Duane Morris LLP, Mr. Swit served for seven years as vice president at a preeminent scientific and FDA regulatory consulting firm, where he developed and ensured execution of a broad array of regulatory and other services to clients, both directly and through outside counsel.

Michael Weickert Strategic & Entrepreneurial Executive, Trail-blazing Leadership in Biotech, Medical Device & Pharmaceutical Business

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Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

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By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.


  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Sponsors, Exhibitors and Media Partners:

    We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

    Benefits of becoming a Sponsor/Exhibitor/Media Partner:

    • Logo on website, marketing email, branding materials & the registration booth
    • Exhibit Space
    • Free event pass
    • Speaking opportunity
    • Social media campaign

    For more details and other sponsorship options at this Summit, please contact Summit Manager: [email protected] or call: +1-650-238-9656


    BSI TOXIKON ThinkMed

    Media Partners:

    CrowdReviews SupplyChainBrain mds journal Packaging-Labelling Plastics-Technology Pharmaceutical-Tech Hospitals-Management SupplyChainBrain Hospitals-Management Hospitals-Management Medtech biotechgate business1 Industry_Events conference-monkey Clinicaltrialvendors

    Past Sponsors, Exhibitors and Media Partners:

    Medical Device Summit Partners & Sponsors


    See What People Say About Summit

    I think the summit was very well run and organized. It provided an excellent environment that was conducive to relaxed and meaningful interactions between FDA, industry, and even foreign medical device regulatory agencies.

    Medical Officer, Center for Devices and Radiological Health,

    U.S. Food and Drug Administration (FDA)

    This event was very focused on FDA regulatory training, standards and guidance. This was the main reason that I attended in this event and the event delivered all with high quality.

    Research and Development Program Manager IV,


    The FDA speakers really added a lot of value. There were many experienced industry speakers & I learned a lot from them.


    Springborne Life Sciences

    The summit was great success on my opinion, very knowledgeable speakers and interesting topics. I extended my network of contacts that beneficiary for our company. Thank you for giving this great opportunity and hoping to attend another one next year.

    Quality Assurance Manager,

    BCSI SAFE Sens

    With notable speaker, a broad range of topics and great networking potential, this conference was an amazingly good investment of time.

    Principal Consultant,

    Shoebar Associates

    There was a very good presence of the FDA, who provided brief regulatory insights.

    President and Chief Scientist,

    HirLan, Inc.

    Excellent mix of topics with great presentations, worth every penny and time we spent there.


    SEAS, Inc

    Excellent speakers, diverse experience and background.

    Senior Manager,

    Global Security Risk Management, Edwards Lifesciences

    Very interesting & informative sessions.


    Device Manufacturing, Vital Therapies

    It was a pleasure to work with ComplianceOnline as the conference organizers. Communication was timely and complete. Support in preparation of the program was excellent and the level of organization was high - as a speaker, all I needed to do was prepare the talk and show up. As a participant listening to other presentations, the content was generally very good and I came away learning more than I contributed.

    President & CEO,

    Directional Healthcare Advisors, LLC

    I thoroughly enjoyed the summit because it gathered speakers of various background (even FDA and ex-FDA officials) to discuss a wide range of topics related to device industry. I learned a great deal of software security and its impact on devices. This is an area that is new and exciting.

    Corporate Regulatory Compliance Manager,

    Quality Packaging Specialists International

    Overall it was good experience. It was great to hear directly from the FDA's perspective. Most of the sessions were thorough and very informative.

    Production Manager,

    Centurion Medical Products

    Excellent presentations with lot of examples. Well Done!

    Senior Director,


    I thoroughly enjoyed the summit. I hope the next summit will also be held in Boston.

    Medical Device Expert,


    The summit was well organized.

    Medical Device Expert,


    FDA speakers were excellent and topics covered were beneficial.

    Quality Manager,

    Fisher & Paykel Healthcare

    A great learning opportunity. Relevant topics with approachable and knowledgeable presenters from industry and regulatory perspective.

    Senior Director,

    Head of Software Management, Philips

    Excellent speakers. All topics were valuable. Excellent participant involvement across the whole group.

    QA-RA Director,

    Easy Sense

    Very informative, learned a lot, got connected with speakers who will help us in designing the product.



    The event was extremely well organized. All topics were useful to me.

    Product Line Manager,


    Lot of useful information and I have learnt a lot. Supplying slide decks to the participants was a master stroke.


    Draeger Medical Systems Inc.

    Excellent speakers. Topics were very helpful.

    Quality System Tech,

    Milliken Healthcare Products

    Excellent speakers. The event was well organized.

    Assistant Director Quality,


    Great presentations and subjects covered.


    Regulation Combination Devices, EMD Serono

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    Frequently Asked Questions:

    I have two discounts I would like to use for my summit registration; can I use both of them?
    No, we do not combine discounts but we will honor the discount that is better for you.

    Are the meals included?
    Yes, all refreshments and summit lunches have been carefully selected to offer you the best in banqueting. Please check the agenda for timings.

    How many attendees will be at my summit?
    This varies for each summit. Please do ask at our registration desk if you would like us to assist in facilitating meetings with anyone present to ensure you receive maximum benefit from the day.

    How can I get to the venue?
    For information on the venue or travelling details to the summit check the “venue” section on the website or contact us if you require further information.

    What about accommodation?
    The cost of the hotel accommodation and travel is not included in the registration fee. To take advantage of our corporate accommodation rate, after completing the registration, please state you are attending ComplianceOnline Medical Device Summit when making your hotel room reservation. Please note that special discounted hotel rooms are limited and available on a first-come, first-serve basis.

    What should I wear?
    Speakers and delegates normally wear formal business attire whilst attending the summit.

    In case of special needs?
    If you have any special needs, disabilities, and/or dietary requirements please do let us know when you register for the event.

    Do I have to pre-select the streams that I want to attend in a multiple stream summit?
    Yes, for planning reasons we will need to know who is attending which stream.

    When should I pay for the summit?
    Payment must be received prior to the summit. To get the early bird price offer, please visit the “Price/Register” section of website.

    How should I pay for the summit?
    The simplest method of payment is via credit card using our secure online bookings. If you wish to book offline, we require written authorization along with credit card details by e-mail to [email protected]. You can also send your PO with summit name and location by fax to +1-650-362-2367. We accept Visa, MasterCard, Maestro and American Express. Pay your check to (payee name) "MetricStream Inc" our parent company and mail the check to: ComplianceOnline (MetricStream, Inc), 2479 East Bayshore Road, Suite 260, Palo Alto, CA 94303.
    If you have any questions concerning payment please feel free to contact our customer service team on +1-888-717-2436.

    How can I get a receipt for my credit card payment?
    There are two ways you can receive a receipt for your credit card payment:
    1. Unless otherwise requested, or if payment is made close to the event date, we will e-mail you your receipt.
    2. We are happy to fax a copy of the receipt for your records until you receive the original. You will need to advise our customer service team which option is preferable.
    I am already busy at the time of the summit; can I still get the materials used?
    Yes, if you know before booking that you cannot attend the summit, you can purchase materials used at the summit.

    When will I receive my summit material?
    Depending on whether you are a delegate or a document purchaser, you will receive your summit material at different times:
    Delegates: Your badge and delegate pack will be available for collection at registration on the first morning of the summit.
    Document Purchaser: Providing that payment has been received documents will be sent out two weeks after the event date.
    Online Document Purchasers: Soft copy will be sent out to you via email two weeks after the event.

    Can I receive a copy of the presentations?
    Yes. All attendees will get a copy of the presentations after the summit. The distribution of presentation materials is subject to the speakers’ permission. If you are unable to attend the event, it is also possible to purchase a CD-ROM that contains presentations from the summit. For more details email us at [email protected].

    What happens if I have to cancel?
    1. Cancellations may be made by phone but must be confirmed in writing within a month of the event, please see the event brochure for individual cut off dates.
    2. Please quote the order number and delegate name when cancelling.
    3. Cancellations must be received in writing. Cancellations received more than one month prior to the summit are subject to a $300 administration charge.
    4. Cancellations within 30 days of event date: In the event of cancellation 100% of the event fee is payable and non-refundable. All cancellation requests must be submitted to us in writing. If we agree to your cancellation then all cancellation fees are payable immediately after the acceptance of your cancellation in writing by us.
    If you cancel a complimentary delegate place or fail to attend you will be liable to pay a cancellation fee of $200 for the event.

    What happens if the event is postponed or cancelled?
    In the event that ComplianceOnline postpones or cancels an event, delegate payments at the date of cancellation/ postponement can either be credited to a future ComplianceOnline event or refunded. This credit will be available for up to one year from the date of issuance. If the delegate is unable to attend the rescheduled event, the delegate is welcome to send a substitute delegate, free of charge, or will receive a credit representing payments made towards a future ComplianceOnline event.

    Can I substitute a delegate?
    Yes, substitution of a delegate is free of charge - we need full registration details before the summit in order to substitute a delegate. For more information on the details feel free to contact our customer service team on +1-888-717-2436.

    Can I register at the summit venue?
    Yes, you may register for summit on site and our registration personnel will be happy to help you. But we would suggest that you register as soon as possible as seats are limited.

    ComplianceOnline is not responsible for any loss or damage as a result of a substitution, alteration, cancellation, or postponement of an event. ComplianceOnline shall assume no liability whatsoever if this event is altered, rescheduled, postponed or cancelled due to a fortuitous event, unforeseen occurrence or any other event that renders performance of this summit inadvisable, illegal, impracticable or impossible. For purposes of this clause, a fortuitous event shall include, but shall not be limited to: an act of God; governmental restrictions and/or regulations; war or apparent act of war; terrorism or apparent act of terrorism; disaster; civil disorder, disturbance, and/or riots; curtailment, suspension, and/or restriction on transportation facilities/means of transportation; or any other emergency.
    Please note that speakers and topics were confirmed at the time of publishing, however, circumstances beyond the control of the organizers may necessitate substitutions, alterations or cancellations of the speakers and/or topics. As such, ComplianceOnline reserves the right to alter or modify the advertised speakers and/or topics if necessary. Any speaker or schedule substitutions or alterations will be updated on our webpage as soon as possible.

    Will I receive any information from you via mail?
    After the summit, from time to time, you may receive updates on related upcoming seminars, webinars and summits.

    Will I receive any e-mails from you?
    If you have opted-in to e-mail communication with ComplianceOnline you will receive related market information and advanced notification of related events.

    Will my contact details be shared with third parties?
    No, ComplianceOnline does not give out your contact details to third parties. From time to time, you may receive information on relevant or related areas from one of our divisions.

    How do I prevent SPAM filters from blocking my alerts?
    Internet Service Providers (ISPs) utilize various methods to prevent unsolicited commercial e-mail (junk mail or spam) from being delivered to users' mailboxes. Some of these methods may mistakenly classify ComplianceOnline Medical Device Summit emails as such and not deliver the alert to the recipient. Each ISP has different set of steps to follow to assure these alerts get delivered directly to the users' mailboxes. Typically the sender's domain name must be added to an address book or 'safe list'. To assure you receive ComplianceOnline Medical Device Summit alerts via e-mail, please add to your address book or safe list. If you still have trouble, please contact the helpdesk via e-mail at [email protected].

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    Local Attractions of Boston, MA

    Boston Public Garden

    Boston Public Garden

    This Frederick Law Olmsted-designed park, famous for its Swan Boats, has over 600 varieties of trees and an ever-changing array of flowers. It is America's first public garden.

    Boston Public Library

    Boston Public Library

    The Boston Public Library was the first large municipally-funded public library in America. It has a central location right in the heart of Copley Square, facing the Trinity Church, easily accessible by taking the Green Line to Copley station (or also near to Orange Line Back Bay stop).

    Fenway Park

    Fenway Park

    Fenway Park is the oldest Major League baseball park in the United States. Its small, intimate atmosphere really allows you to feel like you are "in the game." The park is situated right in downtown Boston - so it is very accessible if you are visiting the area.

    Museum of Fine Arts

    Museum of Fine Arts

    Boston's oldest, largest and best-known art institution, the MFA houses one of the world's most comprehensive art collections and is renowned for its Impressionist paintings, Asian and Egyptian collections and early American art.

    Museum of Science

    Museum of Science

    The Boston Museum of Science is a long-standing tradition for families in Boston, but that doesn't mean adults won't enjoy themselves too! Their exhibits range from dinosaurs to space travel to wildlife to physics to human biology to an in-depth look at Boston's "Big Dig" project.

    North End

    North End

    This Italian neighborhood, Boston's oldest, is known for its wonderful restaurants and historic sights.

    Old North Church

    Old North Church

    The signal from the steeple of Boston's oldest church triggered the War for Independence that led to the birth of America. On that fateful night in 1775, the two lanterns in the steeple told Paul Revere that the British were approaching by boat, not on foot.

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