blue.S4

PRRC under Article 15 of the EU Medical Device Regulation (MDR), including to ensure MDR conformity of devices before they are released. Maintaining technical documentation and keeping Declarations of Conformity updated as required. Oversee the Post-Market Surveillance (PMS) to ensure compliance with MDR Article 10. Including ensuring vigilance obligations are met, including incident reporting. Also to verify compliance with regulatory requirements for medical devices.