Medical Device Consultant & Technology provider

SERVICES

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

Products and Technologies, COVID-19 Products

  • PPE/ Personal Protection Equipment (surgical face masks, medical respirators),
  • 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).