Medical Devices - Consultant
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.