What are the major changes in ISO 14155 2020?

This is an excerpt from the course "Clinical Investigation for Medical Devices and ISO 14155" which is available at: https://medicaldevicehq.com/introduct... You can read more about the changes in the ISO 14155:2020 here: https://medicaldevicehq.com/articles/... Chapters: 00:00 Introduction 00:17 About the instructor 00:50 The new version of the standard 01:57 Some major changes 04:02 Risk management changes 04:57 Other important annexes 05:43 Why is it important? 06:17 Additional resources Don't forget to follow Medical Device HQ on LinkedIn:   / medicaldevicehq