What is new in ISO 14971 2019

This is an excerpt from the course "Introduction to risk management for medical devices and ISO 14971:2019" which is available at:

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Chapters:
00:00 What is new in ISO 14971:2019
02:02 What is the same as before in ISO 14971:2019
03:02 ISO 14971:2019 and GSPR MDR
04:20 ISO/TR 24971:2020 What is new?
05:18 Summary of changes in ISO 14971:2019
08:19 Production and post-production activities in detail
09:05 Inherent safety by design AND MANUFACTURE
09:44 Comparison of old and new risk control options in ISO 14971
10:26 Comparison of ISO 14971:2019 risk control options and MDR
11:35 The ISO 14971:2019 definition of harm
12:28 Cybersecurity in ISO 14971:2019
12:57 Policy for establishing criteria for risk acceptability in ISO 14971:2019
13:57 Content deviations for ISO 14971:2019
14:56 Download free checklist for ISO 14971:2019 update

[jonathanphillips]

Excellent video. In the process of updating a number of risk management files and starting a brand new one!

[DoaaKhalil]

I want to know how to perform risk benefit analysis ??

[engr.emmanuelenyi]

Great job! Quite informative. How may we estaminate risk to the barest minimum?

[ramakrishnahavaldar]

Hi Peter,
The presentation is very informative and thanks for sharing.
I wanted to understand, as a part of new 2019 version of the standard, should we have to specifically list out the reasonably foreseeable misuses about the product?
If yes, where should it be? Is it as a part of intended use & indications of use of the product OR in the Risk management Review file?
Please let us know.