This is an excerpt from the course "Introduction to PRRC - Person Responsible for Regulatory Compliance" which is available at: medicaldeviceh...
Chapters:
00:13 About the instructor
00:39 Introduction to the PRRC
01:44 Course goals
02:34 MDR requirements
03:00 EUDAMED
03:40 UDI (Unique Device Identifier)
04:06 EMDN (European Medical Device Nomenclature)
04:48 QMS (Quality Management System)
05:58 PSUR (Periodic Safety Update Reports)
06:20 GSPR (General Safety and Performance Requirements)
06:40 GSPR requirements
7:35 The MDR (Medical Device Regulation)
08:41 PRRC responsibilities
11:19 PRRC job description
11:52 Other resources
Don't forget to follow Medical Device HQ on LinkedIn:
/ medicaldevicehq
23 окт 2024