Person Responsible for Regulatory Compliance

Medical Device

11/8/2023

Seminar for PRRC position and final exam:

• Legal framework according to MDR Article 15
• Responsibilities, sharing & delegation among several persons
• Job description
• Conformity of devices produced under QMS
• Technical documentation and Declaration of Conformity
• Post-market surveillance system
• Reporting of serious incidents, FSCA and FSN
• Issuing the statement for investigational devices
• Definition of trends and reporting of trends
• Provisions on fines according to German law (MPDG)
• Guidance by MDCG 2019-7, MDCG 2021-25

Go back