FMEA and Risk Management for Medical Devices

John Chapman

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FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management.  FMEA has been used as part of Risk Analysis under the obsolete standard EN 1441 - Risk Analysis for Medical Devices.    The term “Risk Analysis” is no longer appropriate for medical device manufacturers and has been replaced by “Risk Management”.  EN 1441 is now a withdrawn standard and ISO 14971:2007 Medical Devices -- Application of Risk Management to Medical Devices has been the harmonized standard for risk assessment of medical devices under the medical devices directives and has been emphasized in the new ISO 13485:2016.  This presentation will acquaint one with 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.

Areas Covered in the Session:

  • Risk Management vs. ISO 13485
  • Risk Management & ISO 14971
  • FDA’s Risk Management Requirements 
  • Design Control Risk Management
  • Medical Device Directives & Risk Management

Who Will Benefit:

Companies interested in minimizing risk in all areas of manufacturing through the use of risk management tools should sign up for this webinar.

Employees who will benefit include:

  • Quality & Regulatory Professionals
  • Quality System Auditors
  • Manufacturing & Design Engineers
  • Marketing Product Managers
  • Operations Executives

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: John Chapman,

John Chapman, BS, MBA, RAC has over 35 years medical device regulatory experience and over 15 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 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. RAB Accredited Lead Auditor Course Certificate1996. 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. John has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, Auditing, Root Cause Analysis, Design Control, Bloodborne Pathogens, Hazardous Waste Handling, and FDA regulations. He has also presented live on-line seminars on various regulatory and quality system subjects.

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