Course "Creating and Implementing an Effective Risk Management System - Why FMEAs by Themselves are Not Risk Management Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

As technologies and innovation push the boundaries for new medical devices, there is an increased emphasis and expectation that such devices shall be free from unacceptable risk to the patient and end-user. In addition several recent standards and guidance documents point to ISO 14971:2007 as the standard for medical device risk management. Many (incorrectly) assume that the use of Failure Mode and Effects Analysis (FMEA) is compliant with the standard and it is the risk management system for their products. A clear understanding of what is effective risk management has thus become a necessity for medical device manufacturers.

This two day interactive seminar will provide a clear understanding of what constitutes a risk management system and the relationship of FMEAs to risk management. It will also provide attendees with the fundamentals and knowledge to create, improve and implement an effective, compliant risk management system in their organizations.

Learning Objective:

  • Understanding the importance of risk management as the apply to relevant Medical Device Regulations (21 CFR Part 820) and Standards (ISO 13485)
  • Recognizing organizational factors that lead to an effective risk management system
  • Integrating the product life-cycle process with risk management
  • Detailed understanding of ISO 14971 Risk Management for Medical Devices
  • Conducting risk analysis and creating risk documents
  • Understanding the relationship and use of tools like Hazard Analysis, FMEA and FTA
  • Advantages and disadvantages of FMEA with respect to risk analysis
  • Developing a compliant Risk Management File
  • Knowing how to use Risk Management Files in post-production activities
  • Knowing how and when to update Risk Management Files

Who will Benefit:

  • Executive Management
  • Product design and development managers and engineers
  • Operation and manufacturing managers and engineers
  • Quality Control
  • Quality Assurance
  • Consultants
  • Project Managers
  • Contract Manufacturers
  • Suppliers to the Medical Device Industry
  • Complaint Handling Teams
  • CAPA Teams

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:00 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  • Introduction (15 min)
  • Quality Systems Regulation for medical devices overview and intent (60 min)
    • FDA 21 CFR Part 820 and Risk Management
    • ISO 13485 and Risk Management
    • Risk Management Guidance documents overview
    • Trends and expectations in Risk Management
    • FDA Inspections
  • ISO 14971 Overview (60 min)
    • Risk Management Process overview
    • Concept of Normal and Fault conditions
    • Product Life Cycle Concept
    • Collateral Standards (IEC 63266, HE 75, IEC 60601-1-1 3rd Ed. IEC 62304 Etc.)
    • Key terminology
  • Management Responsibilities (60 min)
    • Roles and responsibilities
    • Risk Acceptability Criteria determination
    • Exercise on Risk Acceptability Criteria
  • Risk Management Plan (30 min)
    • RMP Overview
    • Exercise on RMP
  • Risk Analysis Prerequisites (30 min)
    • Hazard List
    • Harms List
    • Questionnaire
  • Risk Analysis Overview (120 min)
    • Design Input and Design and Development Process
    • Use Case Analysis / Intended Use / User Needs
    • Hazard Analysis
      • Hazard / hazardous situation / harm / severity of harm / risk level
      • Risk Controls
      • Individual Residual Risk Analysis / Risk Benefit Analysis
    • Exercise on Risk Acceptability Criteria and Hazard Analysis

  • Design Output (60 min)
    • Use Failure Mode and Effects Analysis (UFMEA)
    • Design Failure Mode and Effects Analysis (DFMEA)
    • Pros and Cons of FMEA
    • Use of Delectability in DFMEA
    • Fault Tree Analysis
    • Exercise on UFMEA and DFMEA
  • Design Transfer (60 min)
    • Process validation
    • Process Failure Mode and Effects Analysis (PFMEA)
    • Exercise on PFMEA
  • Software Risk Analysis (45 min)
    • Basic Principles
    • Examples
  • Final Risk Analysis Summary Table (60 min)
    • Methods of creating a Risk Analysis Table
    • Overall Residual Risk / Risk Benefit Analysis
    • Exercise on Overall Residual Risk And Risk Benefit Analysis
  • Risk Management Report (30 min)
    • Risk Management Report overview
    • Exercise on Risk management Report
  • Risk Management File (15 min)
  • Risk Management in Post-Production (60 min)
    • Use of Risk Files in Post Production (NCRs, Complaints, CAPAs, Change Control etc.)
    • Updating Risk Management Files
    • Health Hazard Evaluation
    • Case Study / Exercise on Post-production
  • Review and Control of Risk Management Files (15 min)
  • Conclusion (15 min)

Meet Your Instructor

Dr. Vinny Sastri
Ph.D, President, WINOVIA® LLC

Dr. Vinny Sastri, Ph.D is the president of WINOVIA® LLC, a company that provides customized solutions, strategies, and implementation of effective product life cycle management and quality management processes. Dr. Sastri has over 25 years of experience in quality, product development and manufacturing. His areas of expertise include FDA and ISO quality management systems and good manufacturing practices (GMP) for medical devices and pharmaceuticals, product life cycle management and design for Six Sigma, design controls, risk management, CAPA, manufacturing, operational excellence, process validation, supplier controls, change management and plastics and materials.

He is a certified Six Sigma black belt and is also on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training on the FDA Quality Systems Regulation and Industry Practice to the medical device industry. He is the author of the book “Plastics in Medical Devices: Properties, Requirements and Applications” published by Elsevier, London in April 2010. He has over 20 publications and 6 patents and has presented at many international conferences and webinars in the United States, Europe and Asia.

Register Now

Online using Credit card

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 [email protected]

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

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 @ [email protected]

Payment is required before 2 days of 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 $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) 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 before 5 working days from 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 use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.

Media Partners


Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Local Attractions

Built in 1915 on the highest point in the city, this cathedral is one of the largest in the country. A replica of St. Peter's in Rome, the building boasts a newly restored 175-foot-high copper dome, a massive rose window, and granite-and-travertine construction.

Set on a bluff overlooking the Mississippi River, the Weisman Art Museum is part of the University of Minnesota campus. You won't miss the trademark Frank Gehry-designed building; its fluid form defies conventional architectural lines, and its metallic finish gleams in the sunlight. The permanent collection is especially strong in American modernist paintings, ceramics, Mimbres pottery, and Korean furniture.

This living history museum commemorates the establishment of a fort here in the wilderness in 1819 by Col. Josiah Snelling and his troops, who opened the area for homesteaders. Costumed guides are the focus of a living history reenactment during the summer months, re-creating the activities of everyday army life during the 1820s.

Minneapolis's Mill City Museum recounts the history of the flour industry that earned the city the nickname "Mill City" in the late 19th century. Set in the ruins of what was once the world's largest flour mill the museum re-creates old milling techniques with period equipment railroad cars and interactive exhibits. Visitors also learn the impact of the nation's first high-quality finely milled flour on the gastronomy of the Twin Cities and the country.

More than 5,000 years and 80,000 pieces of fine and decorative arts comprise the permanent collection at the MIA, including a 2,000-year-old mummy, European masters (Rembrandt, Titian, and Monet, among others), architectural and decorative arts, and a comprehensive photography exhibit. If you're short on time, ask for the "Highlights" brochure to make sure you don't miss the museum's best.

An impressive array of artifacts is housed in this three-story museum, including photographs, music, and videos, all of it celebrating Minnesota history. Kids enjoy sitting in the re-created basement of a Minnesota farmhouse while a simulated tornado passes overhead. Adults enjoy listening to recordings of Minnesota musicians, including Bob Dylan, Steven Greenberg, and Prince.

Temporary exhibits are the rule at the Minnesota Museum of American Art, which overlooks the Mississippi River. Expect edgy, contemporary installation pieces, as well as paintings, fiber art, ceramics, works on paper, and works created from found objects.

"Russia's Grizzly Coast" became the Minnesota Zoo's newest exhibit in 2008 bison pumas and wolverines -- as well as exotic mainstays like tigers camels dolphins and monkeys. The Minnesota Zoo also includes an IMAX theater and a monorail for easy navigation of the grounds.

Located inside the entrance to the Science Museum of Minnesota , the Mississippi River Visitor Center is operated by the National Park Service and designed to educate visitors about the Mississippi National River & Recreation Area. Park rangers can assist travelers with planning outdoor excursions, including canoe and riverboat trips, hiking, biking, and birding. If you're at all outdoorsy, it's worth a stop.

Hands-on exhibits introduce visitors to natural history, science, and technology in this massive museum. Highlights include the Human Body Gallery, navigating a virtual towboat down the Mississippi River, and a collection of fossils and prehistoric specimens. In warm months check out EarthScapes Mini Golf, a new activity designed to teach earth surface dynamics. There's also an Omnitheater.

One of the Midwest's oldest (1851) and most important universities, with 50,000 students on the Twin Cities campus, the UMN offers three significant museums -- the James Ford Bell Museum of Natural History, the University Art Gallery, and the Frederick R. Weisman Art Museum .The 4,800-seat Northrop Auditorium has been a home for distinguished performances since 1929, and the University Theatre has four separate stages.

The Walker Art Center is as well known for its striking architectural features as for the edgy, contemporary art inside: paintings, sculptures, drawings, photographs, and multimedia installations. A fine-dining restaurant and cafe, both by Wolfgang Puck, and gift shop are also new. Across the street is the Minneapolis Sculpture Garden, the largest urban sculpture garden in the country. A variety of 20th-century sculpture shares space with horticultural plantings, including the famous "Spoonbridge and Cherry" sculpture.

We need below information to serve you better



6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube


Copyright © 2021 MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method