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Virtual Training: PRRC | Person Responsible for Regulatory Compliance

六月 03, 2021

Date: 3rd of June (1) and 10th of June (2) 2021 (2 sessions)  

Time: 13:30h - 17:00h CET 

Location: Virtual

Language: English

Costs: € 895,-

The certificate* is optional, and will cost an additional € 375,-

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. Qserve organizes training for persons that will be appointed by manufacturers or Authorized Representatives as PRRC.

There is an option to receive a personal certificate for this training, showing you have successfully qualified as PRRC. The personal certificate will detail the learning objectives, and if you fulfill the requirements of the MDR/IVDR for qualifying as PRRC (experience and background). The certificate is personal and can be shown to Notified Bodies during audits.

Learning objectives
  • Understand the background of MDR/IVDR to understand PRRC requirements and where they are coming from.
  • What are the roles and responsibilities of PRRC.
  • Qualifications of PRRC.
  • Relation of PRRC and your QMS
  • Learn how to appropriately check the conformity of the devices.
  • Understand what checks are proportionate to the risk class and the type of device.
  • How to keep the technical documentation and the EU declaration of conformity up-to-date.
  • Checks to fulfill for Post-market surveillance obligations.
  • Reporting obligations for recording and reporting of incidents and field safety corrective actions.
  • What to do as PRRC if there are devices undergoing clinical investigation (MDR) or performance studies (IVDR).
  • Liability of the PRRC.

Who should attend?

  • Persons that will be responsible for regulatory compliance
  • Authorized representatives
  • RA manager, RA director, QA manager, QA director
  • Professionals preparing for the MDR/IVDR

Trainer

Peter Reijntjes
发布日期: 三月 30, 2021
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