Regulatory affairs, international approvals and registration of medical devices

The way into the market always starts with the first step.

(in adoption of Confuzius)

Experience, competence, solutions

Companies, starting to enter into new markets, are mostly facing difficulties:

  • gathering reliable information
  • registering products
  • listing in databases
  • filling forms
  • preparing documentation
  • applying for approvals
  • performing tests
  • obtaing certification
  • establishing local representations
  • contacting authorities



We obtained our individual competence in the worldwide market of medical products in the intense exchange within our network and the close cooperation with our clients.



New founded small and mid-size companies as well as well established big companies benefit from our know - how.



Solutions are only beneficial if they fit like a tailor-made suit. We develope individual solutions in cooperation with our clients.

We will support you on this way: