Medical Devices - Consultant

SERVICES

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

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

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

  • R&D/Project management, Development, Optimalisation and Production of hardware - software , Cost-reduction- etc.

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

  • Medical Device Product due diligence.

  • Asian market introduction.