Changes in the upcoming Standard ISO 14971:2019

Bijan Elahi

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The third revision of ISO 14971 will be released in Q4, 2019. Upon release it will cancel and replace ISO 14971:2007. In this webinar you will learn what has changed and how to prepare for compliance to the new Standard.

Why Should You Attend:

There are a number of changes to ISO 14971 from the second revision in 2007 to the third revision in 2019.There will be no transition period.Upon release, the third revision (2019) will cancel and remove the second revision (2007).New terms and definitions are introduced; there are changes to the risk management process; postmarket activities are detailed and whole annexes are removed.

Learn what are the changes to ISO 14971 and be prepared, when it is released.There is no transition period.Upon release, the 2019 revision will cancel and remove the 2007 revision.

Areas Covered in the Webinar:

  • Changes to the risk management process
  • New definitions of terms
  • New terms
  • Removal of Annexes
  • Transfer of information to ISO/TR24971
  • Requirements for production and post-production activities
  • Clarifications in the language of the Standard
  • Guidance on when the residual risk in not acceptable

Who Will Benefit:

  • Design engineers
  • Research engineers
  • Quality assurance / Quality engineers
  • Regulatory
  • Clinical

From the medical device and pharma industries.

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Speaker: Bijan Elahi,

ijan Elahi has worked in safety risk management for medical devices for over 25 years at the largest medical device companies in the world, as well as small startups. He started his work in risk management in aerospace; last working on the Space Shuttle at NASA before transitioning to the medical device industry in the early 1990’s.

Bijan is the corporate expert on risk management at Medtronic. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide. Bijan is also a lecturer at Delft University of Technology, and Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the book Safety Risk Management for Medical Devices.