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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.
 

Sullen-gent

Involved In Discussions
#5
That link @Edward Reesor was great and also there is a free checklist on the site as well for the 2019 version. In the process of reviewing our procedure now. It's really strange that labelling is now allowed as a risk mitigation and that is permissible under the MDR which is more stringent, that will take some getting us to.
 

Regulatory

Involved In Discussions
#6
That link @Edward Reesor was great and also there is a free checklist on the site as well for the 2019 version. In the process of reviewing our procedure now. It's really strange that labelling is now allowed as a risk mitigation and that is permissible under the MDR which is more stringent, that will take some getting us to.
Hello!!
Can you please explain how can we download the checklist for the Risk Management 2019 version because I didn't find there any option..

Thanks.
 

Edward Reesor

Trusted Information Resource
#7
Go to the link that I originally posted and in the first paragraph, third sentence, there is a link. The line is, "Use this free checklist" which only takes you to the bottom of the page. There you are asked to enter your information to subscribe and they will email it to you. You can unsubscribe at any time.
 

Regulatory

Involved In Discussions
#8
Go to the link that I originally posted and in the first paragraph, third sentence, there is a link. The line is, "Use this free checklist" which only takes you to the bottom of the page. There you are asked to enter your information to subscribe and they will email it to you. You can unsubscribe at any time.
Thanks a lot,,
 
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