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Short course on PRRC - Person responsible for regulatory compliance

Medical Device HQ

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Short course on PRRC - Person responsible for regulatory compliance

3 748 просмотров · 3 г. назад
Medical Device HQ
19,4 тыс. подписчиков
3 748 просмотров · 3 г. назад
This is an excerpt from the course "PRRC - Person Responsible for Regulatory Compliance" which is available at: https://medicaldevicehq.com/prrc 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