Conformity assessment procedures for medical device manufacturers

This is an excerpt from the course "Introduction to the Medical Device Regulation (EU) 2017/745" which is available at:
medicaldevicehq.com/medical-d...
Read more about conformity assessment procedures for medical device manufacturers here:
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

[@user-sd2hh3uc1q]

Nice, a very informative and clarifying session, Pontus

[@hajranaashkar2103]

I profoundly indebted to you.

[@gerrywhelan7426]

Good presentation, but in my practical experience over many years, there's massive non-conformity in the medical regulatory industry.