ISO 14971 (2019) Released

If you haven’t heard by now, you should know that ISO-14971, Medical devices — Application of risk management to medical devices, has released its 3rd edition, which you can purchase here. We also offer a redline edition of the document available here.

14971 goes over the principles and processes for risk management specifically those pertaining to medical devices and in vitro diagnostic medical devices. Specifically, this will help you identify, control, and monitor the risks and effectiveness of the controls. For more details on the subject, I would suggest checking out our previous posts on the standards easily accessible here and here.

Companion Standard

Photo by Angel Norris from FreeImages

ISO 24971 is also now available for purchase! It has been long awaited but it is finally made it out of committee review. You can grab your own copy here! Don’t for get to ask us about out subscription service.

So What’s New?

Aside from a few new terms and some format changes for accessibility, there a few fundamental changes made to the document. Some of these changes include as per the publisher:

  • a clause on normative references to respect requirements for fixed ISO/IEC directives
  • terms have been updated to match up with ISO/IEC Guide 63:2019
  • Definitions of certain terms such as benefit, state of the art have been added
  • More attention to the benefits of use of medical devices. Benefit-risk analysis has been aligned with terminology used in some regulations.
  • The process descruved can be used for managing risk
  • Requirements to disclose residual risks have been merged into one requirement
  • Results of reviews is now risk management report
  • Requirements for production and post production activities have been restructured and clarified.
  • Several annexes moved to guidance of ISO/TR 24971

If you would like a more detailed representation of the differences between editions, check out the redline edition available here. This is a great option if you want to easily see what was changed without having to spend any time comparing it with the older edition. Change are clearly marked for viability. Ordering redline editions will give you access to both marked and unmarked editions for convenience. You can find an unmarked edition here.

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