Medical Devices - Consultant - Technology Provider
Regulatory support 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.
Medical Device Product due diligence.
Asian market introduction.
Physiotherapy / Rehabilitation: (Muscle stimulators, EMG, ECG, Laser, Ultrasound),
Cryo Therapy (0... -200°C Liquid Nitrogen-free),
Wound healing (micro current).