Medical Device Consultant

Authorized Representative - EC REP

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).