Gap analysis on ISO 14971:2019 with previous revision

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LukasLosigkeit

Starting to get Involved
#3
These things have changed:
  • Normative references have been included
  • The definitions have been updated
  • Greater focus on the benefits of the medical device or IVD
  • Clarification regarding the applicability of the standard for all risks associated with medical devices and IVDs
  • The RM plan must now include criteria for the determination and acceptance of the overall residual risk
  • Updating of requirements regarding the need to disclose residual risks (e.g. for the patient or user)
  • The requirements regarding the RM report have been updated
  • The link with post-market surveillance was further explained
  • Informative annexes have been removed. They are now available in technical report TR/ISO 24971
 

MDRexpert

Involved In Discussions
#4
These things have changed:
  • Normative references have been included
  • The definitions have been updated
  • Greater focus on the benefits of the medical device or IVD
  • Clarification regarding the applicability of the standard for all risks associated with medical devices and IVDs
  • The RM plan must now include criteria for the determination and acceptance of the overall residual risk
  • Updating of requirements regarding the need to disclose residual risks (e.g. for the patient or user)
  • The requirements regarding the RM report have been updated
  • The link with post-market surveillance was further explained
  • Informative annexes have been removed. They are now available in technical report TR/ISO 24971
I believe the current update is quite extensive. So big that there are trainings provided.
 
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