Medical Devices

SERVICES

  • Medical Device Development.

  • Quality Management Systems (ISO13485) training, setup & maintenance.

  • Regulatory support (MDR 2017/245) concerning Medical devices for economic operators (Manufacturers, Authorised Representatives, Importers, Distributers ) .

  • CE certification (MDR), Technical files, Riskmanagement (ISO14971).

  • PRRC Person Responsible for Regulatory Compliance (MDR 2017/745 art 15 person/qualified person).

  • Authorized Representative EC REP