Standards and approvals

We are of course not talking only about ISO 13485. There are a number of supplementary regulations, guidelines and country-specific legislations that will be relevant to you and to us when dealing with medical technology. We have acquired the know-how to deal with the approval process over the years but are also used to consulting application-specific experts as well.

  • ISO 13485, ISO 14971, ISO 60601
  • FDA, GMP, MDR
  • and many more

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