This is an excerpt from the course "Introduction to the Medical Device Regulation (EU) 2017/745" which is available at:
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Read more about post-market surveillance here:
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Chapters:
00:00 Introduction
00:25 About the instructor
01:08 Article 83: Post-market surveillance system of the manufacturer
01:47 The PMS system
03:43 Actively and systematically collecting data
08:42 The post-market surveillance plan
10:05 Sources the PMS plan must include
11:09 PMS plan coverage according to MDR requirements
19:14 Reporting PMS activities
21:00 Additional resources
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