Responsibilities of the PRRC – and methods to manage them

WEBINAR

Course description

Under MDR it is required that all Medical Device manufacturers have, in their organisation (or have available) a “Person Responsible for Regulatory Compliance” (PRRC). It is clearly stated in MDR in several places that the Quality Management System shall ensure compliance with the regulation, and for this purpose the PRRC role is a key element. Still, neither Article 15 where the responsibilities of the PRRC, nor the MDCG Guidance on the role of the PRRC (MDCG 2019-7) provides any guidance on how this shall be implemented and executed, besides simply referring to the responsibilities of the manufacturer. In this webinar we will provide a better understanding of the expectations on the PRRC from a regulatory perspective as well as how this can be addressed using tools that are already part of your Quality Management System.

Program

This webinar provides guidance on how to ensure that your quality management system will support the PRRC, and how compliance to this regulation can be verified per device, or device category, throughout the device life cycle.

Course content

• Responsibilities of the PRRC, according to MDR and the MDCG Guidance
• How to establish the controls needed for the PRRC role, as part of the Quality Management System.
• How to verify implementation through internal audits and Management Review.

Who should attend

The course is suitable for persons working as Quality Manager/ Regulatory Affairs Manager, PRRC, or CEO.

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