This is an excerpt from the course "Introduction to the Medical Device Regulation (EU) 2017/745" which is available at:
https://medicaldevicehq.com/medical-d...

Read more about conformity assessment procedures for medical device manufacturers here:
https://medicaldevicehq.com/articles/...

Don't forget to follow Medical Device HQ on LinkedIn:
  / medicaldevicehq  

Chapters:
00:00 Introduction
00:21 About the instructor
01:02 EC certificate
01:45 Conformity assessment
04:56 QMS Audit
07:14 Clinical evaluation consultation procedure
07:52 PMS and other audits
09:00 Changes and vigilance
10:12 Recertification
11:03 Additional resources