Medical Devices - Consultant - Technology Provider

SERVICES

  • 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.

Technologies,

  • Physiotherapy / Rehabilitation: (Muscle stimulators, EMG, ECG, Laser, Ultrasound),

  • Cryo Therapy (0... -200°C Liquid Nitrogen-free),

  • Shockwave,

  • Isokinetic devices,

  • Diathermy,

  • Hypoxic/hyperoxic therapy,

  • Wound healing (micro current).