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2nd Annual ComplianceOnline Medical Device Summit 2016

Coming soon.. Please contact customer care for new schedule

Course "2nd Annual ComplianceOnline Medical Device Summit 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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Key Attraction

Innovate 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.

Plan 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.

Build 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.

Interact 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.

Deliberate 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.

Scale 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.

Enhance 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.

Get Learning from talks by
  • Ron Brown
    Branch Chief for Medical Device Recalls, FDA
  • Marisa White
    Lead Consumer Safety Officer, Division of Bioresearch Monitoring, Office of Compliance, CDRH
  • Robin Newman
    Director, Office of Compliance at Food & Drug Administration, CDRH
  • Seth D. Carmody, Ph.D
    Cybersecurity Project Manager, CDRH
  • Bakul Patel
    Associate Director for Digital Health at FDA
  • Rick Williams
    Partner, Newport Board Group New England Practice, Chairman of Point Care Technology, Board Member of Amorphex Therapeutics
  • Peter Pitts
    Chief Regulatory Officer, Adherent Health, LLC.
  • French Caldwell
    Chief Evangelist, MetricStream
  • 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
  • Rohit Bedi
    Senior Vice President of Partnerships, MetricStream
  • Minda Wilson
    Founder, Affordable Healthcare Review
  • Stan Mastrangelo
    Professor, Center for Applied Health Sciences, Virginia Tech University
  • Fletcher Wilson
    CEO and Founder, InterVene Inc
  • Patrick Rousche
    Co-Founder and Chief Scientific Officer, Hemotek Medical, Inc
  • David Nettelton
    Industry Leader, Author, and Teacher for 21 CFR Part 11, Annex 11, HIPAA, Software Validation, and Computer System Validation
  • Brian Shoemaker
    Ph.D., Principal Consultant, ShoeBar Associates
  • Geetha Rao
    CEO, Springborne Lifesciences
  • Keith Morel, Ph. D
    VP, Regulatory Compliance, Qserve Group US Inc
  • Scott Phillips
    President, Starfish Medicals
  • Virginia A. Lang, PhD
    President & Chief Scientist, HirLan, Inc.
  • Andrew Pfeifer
    Account Executive, REED TECH
  • Bahaa Moukadam
    CEO, SeeMetrics Partners
  • Angela Bazigos
    CEO, Touch Stone Technologies Silicon Valley
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
  • Learn more about Medical Device Single Audit Program (MDSAP) and Other Third Party Programs
  • Explore upcoming changes in global regulation
  • Supply Chain Optimization
  • Criteria for Medical Device commercialization success
  • Panel Discussion
    • Advanced Technology
    • How to choose Vendors/Suppliers
Find out who had attended the Medical Device Summit 2015 by completing the short form below.



Sponsors, Partners and Exhibitors:
Sponsors Exhibitors Partners


Format:


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.





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.



Multiple Tracks

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



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.





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.



Download Seminar Brochure



Time Mins DAY-1 Sessions
8:00AM - 8:30AM 30 Mins Registration and Breakfast
8.30AM - 8.35AM 5 Mins Opening Ceremony and Introduction
8.35AM - 8.45AM 10 Mins Welcome Speech with an Introduction of ComplianceOnline & Summit
8.45AM - 9.10AM 25 Mins Medical Devices and the Future of Outcomes Centricity
Peter Pitts
Chief Regulatory Officer, Adherent Health, LLC.
9.10AM - 9.40AM 30 Mins FDA Enforcement - Outlook & Implications - Panel Discussion
Rick Williams (Moderator)
Partner, Newport Board Group New England Practice, Chairman of Point Care Technology, Board member of Amorphex Therapeutics
Virginia A. Lang, PhD
President & Chief Scientist, HirLan, Inc.
Angela Bazigos
CEO, Touch Stone Technologies Silicon Valley
Marisa White
Lead Consumer Safety Officer, Division of Bioresearch Monitoring, Office of Compliance, CDRH
9.40AM - 10:20AM 40 Mins Benefit-Risk: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance,
and Enforcement Decisions
Robin Newman
Director, Office of Compliance, Center for Devices and Radiological Health, FDA
10:20AM - 10:40AM 20 Mins UDI Granular Interpretation & Road Ahead
Andrew Pfeifer
Account Executive, REED TECH (Gold Sponsor)
10:40AM - 11:10AM 30 Mins Digital Health and Medical Devices
Scott Phillips
President Starfish Medical
11:10AM - 11:25AM 15 Mins Networking Coffee/Tea Break
11:25AM - 12:05PM 40 Mins Medical Device Recall and Complaint Management
Ron Brown
Branch Chief for Medical Device Recalls, FDA
12:05PM - 12.30PM 25 Mins Medical Device Cyber Security (Remote)
Seth D. Carmody, Ph.D
Cybersecurity Project Manager, CDRH
12:30PM - 01:30PM 60 Mins Lunch Break

Track A - Sessions Track B - Sessions
1.30PM - 2.00PM 30 Mins 1.30PM - 2.00PM 30 Mins
Getting Non-dilutive Funding via SBIR Government Grants for
Medical Device Development

Patrick Rousche
Co-Founder and Chief Scientific Officer, Hemotek Medical, Inc
Interoperable Medical Devices and Connected Medical Networks
Geetha Rao
CEO, Springborne Lifesciences
2:00PM - 2.40PM 40 Mins 2:00PM - 2.40PM 40 Mins
Onward to Approval: Documenting Development for Regulatory Compliance
Brian Shoemaker, Ph.D.
Principal Consultant, ShoeBar Associates
Clinical Evaluation in the EU for Medical Devices - Changing Expectations
Keith Morel, Ph.D.
VP, Regulatory Compliance, Qserve Group US Inc.
2.40PM - 3.00PM 20 Mins Networking Coffee/Tea Break
3.00PM - 3.30PM 30 Mins Wearable Devices (Remote)
Bakul Patel
Associate Director for Digital Health at FDA
3.30PM - 4.10PM 40 Mins Risk Management for Medical Devices - Workshop
Stan Mastrangelo
Professor, Center for Applied Health Sciences, Virginia Tech University
4.10PM - 4.30PM 20 Mins Closing Remarks - Next Day Plan




Time Mins DAY-2 Sessions
8.00AM - 8.30AM 30 Mins Registration and Breakfast
8:30AM - 9.00AM 30 Mins FDA Data Integrity Program
Marisa White
Lead Consumer Safety Officer, Division of Bioresearch Monitoring, Office of Compliance, CDRH
9.00AM - 9.30AM 30 Mins Bringing Compliance to the Boardroom - Panel Discussion
French Caldwell
Chief Evangelist, MetricStream
Angela Bazigos (Moderator)
CEO, Touch Stone Technologies Silicon Valley
Rick Williams
Partner, Newport Board Group New England Practice, Chairman of Point Care Technology, Board member of Amorphex Therapeutics
Bahaa Moukadam
CEO, SeeMetrics Partners
9.30AM - 10.00AM 30 Mins FDA Upcoming Electronic Submission Process
Ron Brown
Branch Chief for Medical Device Recalls, FDA
10.00AM - 10.30AM 30 Mins Medical Device Recall and Complaint Management
Ron Brown
Branch Chief for Medical Device Recalls, FDA
10.30AM - 10.55AM 25 Mins What Investors are Looking for In Medical Devices
Rick Williams
Partner, Newport Board Group New England Practice, Chairman of Point Care Technology, Board member of Amorphex Therapeutics
10.55AM - 11.10AM 15 Mins Networking and Coffee/Tea Break
11.10AM - 11.40AM 30 Mins How Patent and Regulatory Exclusivity can Protect Your Business
Michael Weickert
Strategic & Entrepreneurial Executive, Trail-blazing Leadership in Biotech, Medical Device & Pharmaceutical Business
11.40AM - 12.15PM 35 Mins Compliance as an Element of M&A Strategy - Panel Discussion
Rick Williams (Moderator)
Partner, Newport Board Group New England Practice, Chairman of Point Care Technology, Board member of Amorphex Therapeutics
Michael Weickert
Strategic & Entrepreneurial Executive, Trail-blazing Leadership in Biotech, Medical Device & Pharmaceutical Business
French Caldwell
Chief Evangelist, MetricStream
12.15AM - 12.45PM 30 Mins Future Trends in Healthcare and How You Can Profit From Them
Minda Wilson
Founder, Affordable Healthcare Review
12.45PM - 1.45PM 60 Mins Lunch Break

Track A - Sessions Track B - Sessions
1.45PM - 2.25PM 40 Mins 1.45PM - 2.25PM 40 Mins
FDA Compliance for SaaS/Cloud Environments
David Nettelton
Industry Leader, Author, and Teacher for 21 CFR Part 11, Annex 11, HIPAA,
Software Validation Computer System Validation
Human Factors Compliance: Just Another “Hoop” or Good Business?
Virginia A. Lang, PhD
President & Chief Scientist, HirLan, Inc.
2.25PM - 2.50PM 25 Mins 2.25PM - 2.50PM 25 Mins
The New Off-Label
Peter Pitts
Chief Regulatory Officer, Adherent Health, LLC
FDA Quality Metrics Update
Angela Bazigos
CEO, Touch Stone Technologies Silicon Valley
2.50PM - 3.10PM 20 Mins 2.50PM - 3.10PM 20 Mins
Developing a Global Strategy for Labelling
Daphne Walmer
Thought Leader/Expert/Consultant in Medical Device Labeling and Technical Communications
Early R&D Best Practices from Concept to First in Human Studies
Fletcher Wilson
CEO, InterVene, Inc

3.10PM - 3.25PM 15 Mins Networking Coffee/Tea Break
3.25PM - 4.00PM 35 Mins Vendors/Suppliers - Are You Choosing them Right? - Panel Discussion
Angela Bazigos (Moderator)
CEO, Touch Stone Technologies Silicon Valley
Peter Pitts
Chief Regulatory Officer, Adherent Health, LLC.
Daphne Walmer
Thought Leader/Expert/Consultant in Medical Device Labeling and Technical Communications
4.00PM - 4.15PM 15 Mins Closing Remarks & Certificates




Speakers from FDA
Ron Brown
Branch Chief for Medical Device Recalls, FDA
Marisa White
Lead Consumer Safety Officer, Division of Bioresearch Monitoring, Office of Compliance, CDRH
Robin Newman
Director, Office of Compliance, Center for Devices and Radiological Health, FDA
Seth D. Carmody, Ph.D
Cybersecurity Project Manager, CDRH
Bakul Patel
Associate Center Director for Digital Health at FDA
Experts from Industry
Rick Williams
Partner, Newport Board Group New England Practice, Chairman of Point Care Technology, Board member of Amorphex Therapeutics
French Caldwell
Chief Evangelist, MetricStream
Michael Weickert
Strategic & Entrepreneurial Executive, Trail-blazing Leadership in Biotech, Medical Device & Pharmaceutical Business
Minda Wilson
Founder, Affordable Healthcare Review
Fletcher Wilson
CEO and Founder, InterVene Inc
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
Scott Phillips
President, Starfish Medicals
Andrew Pfeifer
Account Executive, REED TECH
Angela Bazigos
CEO, Touch Stone Technologies Silicon Valley
Peter Pitts
Chief Regulatory Officer, Adherent Health, LLC.
Daphne Walmer
Thought Leader/Expert/Consultant in Medical Device Labeling and Technical Communications
Rohit Bedi
Senior Vice President of Partnerships, MetricStream
Stan Mastrangelo
Professor, Center for Applied Health Sciences, Virginia Tech University
Patrick Rousche
Co-Founder and Chief Scientific Officer, Hemotek Medical, Inc
Brian Shoemaker, Ph.D.
Principal Consultant, ShoeBar Associates
Keith Morel,Ph.D.
VP, Regulatory Compliance, Qserve Group US Inc.
Virginia A. Lang, Ph.D.
President & Chief Scientist, HirLan, Inc.
Bahaa Moukadam
CEO, SeeMetrics Partners


Ron Brown
Branch Chief for Medical Device Recalls, FDA



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.



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).



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 at 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



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.



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.



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.



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.



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



Rohit Bedi
Senior Vice President of Partnerships, 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.



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.



Stan Mastrangelo
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.



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.



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



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.



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.



Geetha Rao
CEO, Springborne Lifesciences



Keith Morel, Ph. D
VP, Regulatory Compliance, Qserve Group US Inc

Dr. Keith Morel is VP of Regulatory Compliance at Qserve Group, the largest EU based medical device consulting company. He heads up the Redwood City office, which along with the Boston, Amsterdam (HQ) and Nanjing make up Qserve’s main office locations.

He has worked in the medical device industry since 2000. Prior to joining Qserve, he was Senior Director or Regulatory Compliance at Accuray (a radiation oncology medical device manufacturer) where he was responsible for Internal and External audit processes & execution, Management Review, QMS design & governance and the internal Training process. He was also a Senior Project Manager for DEKRA Certification Inc. for 9 years. During his time at DEKRA he was lead auditor for CE (MDD) & ISO 13485:2003 and performed more than 100 audits & more than 200 Design Dossier/Technical File reviews. He was also DEKRA’s senior cardiovascular product expert, as well as a drug-device combination product expert and he holds an ASQ Certified Biomedical Auditor and a CMDCAS auditor certification.

Dr. Morel has also worked in R&D in the Medical Device industry in various roles as Engineer, Manager and Director, for several technologies including IVUS catheters and super-oxidized water products. He has both a Ph. D. in Plasma Physics (Nuclear Fusion) and a First Class Honours degree in Physics from Imperial College of Science, Technology and Medicine, in the UK



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.



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.



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.



Bahaa Moukadam
CEO, SeeMetrics Partners

Mr. Moukadam’s current focus is to apply his passion for success to support Executives expand their capacity to lead, grow, and profit, while having more time and less anxiety. His extensive experience in international business has given him deep perspective in how business is conducted within various cultures, and his strong analytic and communication skills have enabled him to be a catalyst in infusing life into a long stalled business unit (once); turbo charging top line growth (twice); and turning around failing organizations (three times).

Mr. Bahaa Moukadam is a Global Senior Executive, Coach, Consultant, and Angel Investor. He is a battle-tested executive with P&L and General Management expertise rooted in operational accomplishments in both turnaround and growth environments. Mr. Moukadam is a strategic force in international business and channel development, innovative product creation, marketing, hyper growth, M&A, turnarounds, strategic partnerships, and team and organizational development.

Most recently, Mr. Moukadam served as CEO at Sunrise Telecom, a Silicon Valley technology company. While at Sunrise, he top graded the Executive team, improved product development execution, expanded the sales channel, re-engaged employees, and implemented a quantum leap improvement in the customer experience resulting in rapid business revitalization.

Prior to Sunrise Telecom, Mr. Moukadam made significant contributions to the success of Spirent Communications, Hewlett Packard, and Wandel & Goltermann (now part of JDSU). Mr. Moukadam holds an M.S.E.E. from the University of Kansas and a B.S.E.E. from the University of Missouri.



Angela Bazigos
CEO, Touch Stone Technologies Silicon Valley

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.





Register Online


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at customercare@complianceonline.com


Register by P.O. / Check


Yes, I want to attend "2nd Annual ComplianceOnline Medical Device Summit 2016".

If you are paying by check:

Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Suite 200
Palo Alto, CA 94303
USA

Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

Register by Wire Transfer




Terms & Conditions to Register for the Seminar/Conference/Event

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 @ customercare@complianceonline.com

Payment:
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.

Attendance confirmation and documents to carry to the seminar venue:
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.

Conference photograph / video:
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.

As a sponsor and exhibitor, you will share your expertise, showcase your technologies, products, and services, and network with decision-makers from the Medical devices and the renowned R & D experts technology innovators manufactures etc. We are pleased to offer several exhibitor and sponsorship options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Table-Top Exhibitor Package

Table-Top – Your table-top will be positioned in the exhibit hall. The exhibit hall will be open on both the days for the event and during all breaks. Lunch will also be served inside the exhibit hall. Your package includes:

  • Logos on website, marketing email, branding materials & the registration booth
  • One (2’ x 6’) draped table and one chair
  • Exhibitor can bring banner stands or a pop-up booth not to exceed 8’ x 8’
  • Two conference passes

* A confirmation package will be emailed to you with all the conference details, including table-top number.

For more details and other sponsorship options at this Summit, please contact Summit Manager: summit@complianceonline.com or call: +1-650-620-3937



Sponsors

MetricStream
Platinum Sponsor
ReedTech
Gold Sponsor



Event Exhibitors

PTC
MarcoCare
recombinetics
IDAHO STATE UNIVERSITY



Media Partners

JMDR
Technology Network
MNT
ConferenceGuru
MMM
Morf Media
Sponsors:

MetricStream (Platinum Sponsor):
MetricStream is the market leader in enterprise-wide Governance, Risk, Compliance (GRC) and Quality Management Solutions. MetricStream solutions are used by leading global corporations in diverse industries such as Financial Services, Healthcare, Life Sciences, Energy and Utilities, Food, Retail, CPG, Government, Hi-Tech and Manufacturing to manage their risk management programs, quality management processes, regulatory and industry-mandated compliance and other corporate governance initiatives. MetricStream’s customers include UBS, Société Générale, Pfizer, Philips, Cummins, Kellogg’s, Mondelez International, SanDisk, and NetApp. MetricStream also owns and operates the www.ComplianceOnline.com portal - the largest GRC advisory network and one of the largest GRC communities. MetricStream is headquartered in Palo Alto, California, USA (www.metricstream.com).

Reed Tech (Gold Sponsor):
Reed Technology and Information Services Inc. (Reed Tech), based in Horsham, PA, is a leader in data capture, conversion and content management. Reed Tech is a LexisNexis company; LexisNexis is headquartered in Dayton, OH. It is a leading global provider of comprehensive and authoritative legal, news and business information, as well as tailored applications.



Exhibitors:

PTC:
PTC solutions for Computer Aided Design (CAD), Product Lifecycle Management (PLM), Application Lifecycle Management (ALM), Service Lifecycle Management (SLM), and Internet of Things (IoT) enable process transformation and deliver closed-loop lifecycle management for products and services that are increasingly smart and connected. Our solutions help you optimize the activities within individual functions of your organization, and align them across your entire enterprise—from engineering to supply chain and manufacturing, to sales and service.

MakroCare:
MakroCare's MedTech division specializes Regulatory Affairs, Scientific Affairs and Medical areas for global device and diagnostic firms. In addition, our specialized areas include Regulatory Information management (with ViSU tool), Risk Management, CERs and Vigilance activities including MDR processing. For further details, please visit http://www.makrocare.com/regulatory/consulting/medical-device.





Local Attractions

The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.




Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.




Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.




The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.




Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.




Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.




In Spanish, La Jolla means "the jewel," an apt name for a pretty, Mediterranean-style seaside town - sitting on cliffs flanking the ocean.
La Jolla visitors like to shop and eat in the nice restaurants, some of them with lovely ocean views. There's a lot for the active visitor, too, including ocean kayaking, tide pool-hopping, surfing at Windansea Beach, biking or running along the waterfront.






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 summit@complianceonline.com. You can also send your PO with summit name and location by fax to +1-650-963-2556. 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), 2600 E. Bayshore Road, Palo Alto, CA 94303.
If you have any questions concerning payment please feel free to contact our customer service team on +1-650-284-1695.

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 summit@complianceonline.com.

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 $200 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 +1-650-284-1695.

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.

Indemnity
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 www.complianceonline.com to your address book or safe list. If you still have trouble, please contact the helpdesk via e-mail at summit@complianceonline.com.



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