What is new in ISO 14971 2019

Описание: This is an excerpt from the course "Risk Management for Medical Devices and ISO 14971:2019" which is available at:
https://medicaldevicehq.com/risk-mana...

Starting October 2023, the templates mentioned in the video are no longer available for free on Medical Device HQ. However, more comprehensive paid versions are now accessible via this link: https://medicaldevicehq.com/templates/

We offer premium templates for free to our newsletter subscribers. Instant access to some templates is granted upon subscription. Others will be distributed periodically as part of our newsletter email campaigns.

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