Medical Devices
SERVICES
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