Date: 5th of November 2020
Time: 15:00h -17:00 CET
Costs: € 395,-
Package deal (12 sessions): € 3750.-*
* Team Members with Different Roles & Responsibilities? No problem! We offer flexible options for your company, team, or individual experts. You can send different delegates from your company to the sessions and still qualify for the package.
The MDR and IVDR require that manufacturers and Authorized representatives have a person responsible for regulatory compliance. Article 15 of the MDR/IVDR determines the expertise and responsibilities. These have been further clarified in the recent guidance MDCG 2019-07.
- Understand the background of MDR/IVDR to understand PRRC requirements and where the are coming from
- Identity the role and responsibilities of PRRC
- Understand how to implement the responsibilities of the QMS
- Understand the liability (or not?) of the PRRC