Medical Device Consultant & Technology provider

SERVICES

  • Regulatory support for Quality Management Systems (ISO13485), Riskmanagement ISO14971, MDD & MDR, CE certification, IEC60601.
  • Technical documentation.
  • R&D/Project management, Development, Optimalisation and Production of hardware - software , Cost-reduction- etc...
  • Medical Device Product due diligence.
  • Asian market introduction.

TECHNOLOGIES

  • Muscle stimulator - EMG - ECG
  • LASER
  • CRYO (0... -200°C Liquid Nitrogen-free)
  • Shockwave
  • Ultrasound
  • Isokinetic devices
  • Diathermy
  • hypoxic/hyperoxic therapy
  • Wound healing (micro current)

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