PRRC

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

Certification

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.

The certificate costs € 375,-.

Registration

We offer open enrollment, on-location, and train-the-trainer formats. Please contact us to schedule in-house training, which is recommended for training multiple colleagues or teams simultaneously.