Screenmed sp. z o.o.

IVDR regulatory compliance (PRRC, Art. 15), including oversight of the QMS; review of technical documentation and regulatory files; verification that conformity assessment requirements are met prior to product release and that the EU Declaration of Conformity is maintained; supervision of performance evaluation and PMS/PMPF; ensuring compliant vigilance activities (incidents, FSCA reporting); and coordination of regulatory change control and audit/inspection readiness.