Training

MDR Suite #3: PRRC | Person Responsible for Regulatory Compliance

November 05, 2020

Date: 5th of November 2020

Time: 15:00h -17:00 CET 

Location: Virtual

Language: English

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.

Introduction:

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.

Learning objectives:

  • 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

Trainer: 

Peter Reijntjes
Post date: September 24, 2020
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