Medical Device Risk Management A to Z – Best Practices for Effectiveness and Efficiency: 2-day In-person Seminar

By: Dr. Harvey Rudolph, HRRM, LLC (Ex-FDA Official, ISO 14971 Standard Co-Author)
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Course Description:

FDA views risk management as an essential process both during inspections and in the review of pre-market submissions. Effective risk management has become critical to medical device manufacturers and this interactive two day seminar is aimed at providing medical device professionals with the tools necessary for effective risk management implementation in device manufacturing and marketing.

It will address both the fundamentals of risk management as well as current best practices for ISO 14971 compliance. The course will look in detail at risk management requirements in the US, the EU, and other parts of the world. Taught using an interactive workshop format, attendees will practice all the risk management activities required by ISO 14971. Exercises are aimed at demonstrating efficient and effective use of risk management, including best practices in applying the ISO standard. Emphasis is placed on practical solutions to practical problems. Seminar instructor Harvey Rudolph, Ph.D., one of the authors of ISO 14971 and a 25 year veteran of FDA, will also provide insight on the guidance contained in new ISO TR 24971 (Guidance on the application of ISO 14971) and how to integrate risk management into your quality management system.


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Seminar Instructor Dr. Harvey Rudolph is an ex-FDA official having spent 25 years with FDA and one of the authors of ISO 14971. He will provide insight on the guidance contained in new ISO TR 24971 (Guidance on the application of ISO 14971) and how to integrate risk management into your quality management system.

Learning Objectives:

  • To educate attendees on the vital reasons for risk management and the key role it plays in the product life cycle
  • To demonstrate the requirements of ISO 14971, how they reflect FDA concerns
  • To clarify how risk management impacts international standards, such as IEC 60601, and how to conform to risk management requirements
  • To provide practical application experience and skills in the process and tools of risk management, enabling attendees to be effective risk managers
  • To teach how to establish a quantitative risk management system and one that complies with EN/ISO 14971:2012
  • To provide attendees with the Dos and Don’ts for an effective and efficient risk management system

Who will benefit:

  • Project managers
  • Quality managers and staff
  • R & D managers and staff
  • Regulatory and compliance managers and staff
  • Anyone with risk management responsibilities

Topic Background:

The 3rd edition of IEC 60601 adds further fuel to the fire with the requirement that electro-medical device manufacturers have a risk management process in place conforming to ISO 14971. Manufacturers that market devices in the European Union have found additional requirements for their risk management activities as detailed in EN/ISO 14971:2012.

Course Outline

Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

  1. Introduction
    • What is risk management?
    • Global requirements
    • ISO 14971
    • New European requirements and EN/ISO 14971:2012
  2. Risk management essentials and requirements
    • Risk management philosophy
    • Role of Management
  3. Establishing a risk management policy
    • Required inputs
    • Developing a workable policy (Exercise)
  4. Risk management planning
    • Necessary elements
    • Relationship with quality planning
  5. Risk acceptability criteria/constructing a risk chart
    • Defining the product
    • Measuring risk (Exercise)
    • How to establish risk acceptability criteria
    • EN/ISO 14971:2012 requirements
    • Construct a practical example
  6. Preliminary analysis
    • Safety analysis (Exercise)
    • Hazards and hazardous situations
    • Identifying hazards and hazardous situations (Exercise)
  7. Risk Analysis tools
    • What's available
    • Use and utility of tools (Exercise)
  8. Estimating risk
    • Quantitative and qualitative risk estimation (Exercise)
    • Pitfalls such as software
    • Practical example (Exercise)
  9. Using standards and risk management
    • New guidance from ISO
  10. Risk Evaluation and Risk Control
    • Using a risk chart (Exercise)
    • Use of ALARP
    • Option analysis for risk control
Day Two (8:30 AM – 04:30 PM)
  1. Risk Control (continued)
    • The iterative process
    • Practical example (Exercise)
    • Verification, residual risk and completeness
    • Satisfying EN/ISO 14971:2012
  2. Risk/benefit analysis
    • EN/ISO 14971:2012 requirement
    • How to do it?
  3. Overall residual risk & the risk management report
    • New ISO guidance on evaluating overall residual risk
    • Content and use of the Risk Management Report
  4. Assessing production & post-production information
    • What are the requirements?
    • What you need to do
    • New guidance from ISO
  5. Wrap up
    • Risk management philosophy
    • Risk management and the quality management system
    • Helpful hints

Meet Your Instructor

Harvey Rudolph
Harvey Rudolph
HRRM, LLC (Ex-FDA Official, ISO 14971 Standard Co-Author)

Dr. Harvey Rudolph is an independent risk management consultant specializing in process development and training in risk management. He has been a member of the Joint Working Group on Risk Management since it began in 1995 and is a primary author of ISO 14971. Currently he co-chairs the US Technical Advisory Group for that standard and is working on the new ISO risk management guidance document.

His 37 years experience with medical devices include 25 years at FDA, where he held a variety of positions and retired as deputy director of the medical device laboratory. He also worked for seven years at Underwriters Laboratory, where he was the global program manager for medical devices developing programs to help clients deal with the global medical device environment.

He brings a wealth of knowledge and practical experience to this risk management workshop, having trained and consulted for numerous large and small companies throughout the world.

Venue

Location:
Berlin, Germany (Venue to be announced shortly)

October 9-10, 2014
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