What are the Responsibilities of a PRRC?

Roles & Responsibilities of a PRRC

✿ Checking the conformity of devices against the QMS and controls before they are released.
✿Ensuring that the technical documentation and declaration of conformity is drawn up and kept up to date
✿ Fulfilling the obligations related to post market surveillance
✿Complying the reporting obligations and investigating vigilance issues.
✿ It is also required that the PRRC has the responsibility for regulatory compliance for devices on the market, in clinical trials and clinical performance studies.