FMEA & Risk Management for Medical Devices


Tuesday, March 26, 2019   |   10:00 AM PDT | 01:00 PM EDT   |   Duration: 60 Minutes          

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  Duration: 60 Minutes  

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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.

John Chapman   Product Id : 502382
  Instructor : John Chapman

  More Trainings by this Expert


Overview:

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 The term "Risk Analysis" is no longer appropriate for medical device manufacturers and has been replaced by "Risk Management".

EN 1441 is now a withdrawn standard and ISO 14971:2007 Medical Devices Application of Risk Management to Medical Devices has been the harmonized standard for risk assessment of medical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.

Why should you Attend: The importance of Risk Management is currently emphasized by FDA and ISO 13485:2016 for all QMS processes with FMEA a key tool for good reasons, including recalls and other significant economic losses.

Failure to understand the relationship between risk and economics will put you at a loss while the rest of the team embraces the program.

Areas Covered in the Session:

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


Speaker Profile
John Chapman, BS, MBA, RAC has over 35 years medical device regulatory & compliance 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 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. John has participated in several FDA remediation projects involving non-compliance with all QMS sub-systems. 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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