Medical Device Consultant
Authorized Representative - EC REP
SERVICES
SERVICES
Regulatory support (MDR 2017/245) concerning Medical devices for economic operators (Manufacturers, Authorised Representatives, Importers, Distributers ) .
Authorized Representative EC REP
CE certification (MDR), Technical files, Riskmanagement (ISO14971).
PRRC Person Responsible for Regulatory Compliance (MDR 2017/745 art 15 person/qualified person).