At Biopôle since 2016.

The Leading European Consultancy Service exclusively supporting Medical Devices and In-Vitro Diagnostics compliance with international regulatory requirements


Medidee provides expertise for validation and market introduction of:

  • Medical Devices including surgical tools, implants, active devices, robotic device, active implants and medical equipment
  • In-vitro Diagnostics including self-test, bedside and laboratory equipment

Our services cover all quality, regulatory and clinical activities required at each steps of a medical device lifecycle, from the initial project idea to certification or regulatory clearance. We support our customer in ensuring regulatory requirements are efficiently implemented and contribute to the interactions with regulatory bodies

Based in Switzerland, Denmark, Germany and USA, we are active in Europe, Asia, Australia and both North and South America.

We provide extended information and material to facilitate the regulatory process for our customers. Medidee is ISO 9001 and ISO 13485 certified.

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