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FMEA and Risk Management for Medical Devices

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: US$295.00
  • Refund Policy


This presentation will explain the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

FMEA (Failure Mode & Effects Analysis) is only a segment of Risk Management, but quite valuable for assessing Risk as part of Risk Management. Now that EN 1441 Risk Analysis is obsolete & upgraded to 14971 Medical Devices -- Application of Risk Management to Medical Devices, all facets of risk management must be considered from cradle to grave. The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by "Risk Management".

Areas Covered in the Session:

  • Failure Mode Analysis Terms
  • Risk Management and FDA
  • Risk Management in Design Control
  • Risk Management & ISO 14971
  • Risk Management in Design Control
  • Risk Management & ISO 14971
  • Risk Management & Medical Device Directives

Who will Benefit:

  • Regulatory Professionals
  • Quality Engineers
  • Manufacturing Engineers
  • Operations Executives
  • QA Managers
Speaker Profile
John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.

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