Short course on PRRC - Person responsible for regulatory compliance

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  • Опубликовано: 9 сен 2024
  • 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
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