Ask an expert: Experts answer to your specific and crucial questions

Ask an expert: Experts answer to your specific and crucial questions

Get answers and help, absolutely free and with no obligation

Do you have questions or need help with:

  • Classification of your products,
  • Market approval process (e.g. Europe/CE-marking or US/FDA)
  • Development of an ISO 13485 or FDA compliant QMS,
  • Writing documentation for market approval (e.g. the risk management file, the software file (software architecture, software requirements specification, ...), design history file, clinical evaluation, etc.)
  • Or the preparation of an audit or a "CE Certification"?

From December 19, 2020 to January 10, 2021 we will be on Christmas vacation and therefore can only respond in urgent cases.
We will get back to you as soon as we can afterwards with a response to your request.

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Our Promise

  1. We guarantee 100% confidentiality
  2. If your case is beyond the scope of what we offer for free, we will let you know.There will be no (unplanned) costs.
  3. We respond within 48 Hours during working days (Mo-Fr).
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