What is new in ISO 14971 2019

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