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Medical Devices

Medical devices and durable medical equipments

  • Reporting, assistance with licensing, and coordination on request
  • Translation, adaptation, verification of label text and user information
  • Preparation of clinical documentation:
    • literature background (State of the Art)
    • clinical evaluation plan
    • clinical evaluation
    • writing a clinical protocol
    • clinical trials


  • Categorization
  • Verification of technical documentation
  • Assisting in compliance to MDR (EU 2017/745)
  • Providing responsible person
  • Development of medical devices