The PRRC has the responsibility for regulatory compliance for devices on the market, in clinical trials and clinical performance studies. This is conducted by 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 as well as reporting and investigating vigilance issues. It is also required that the PRRC controls the conformity of devices before they are released.
For micro and small size companies, QAdvis can act as PRRC on behalf of the manufacturer. We are a team of highly competent and experienced quality and regulatory professionals, one consultant will be assigned the role, but with requirements of being continuously available, the team is prepared to step in when needed and in cases of urgency.