Just one question: which of these options suits you best?


Regulatory Support

Do you need Regulatory support?

Regulatory Support

New to the industry or experienced? Either way, regulatory demands can be overwhelming.

Regulation often states why and what, but as a manufacturer you need to know how. We know the how. And we want you to not feel alone. Therefore we provide internal and external support with your certification process, by:

  • conducting design review and compliance pre-assessment to standards like IEC 60601-1, IEC 62304, IEC 62366, IEC 60950, IEC 61010 and ISO 14971 (please ask for other standards)
  • writing regulatory rationales and documents
  • guidance and accompaniment in Notified Body discussions
  • guidance and accompaniment on product safety testing and EMC testing at accredited test laboratories
  • chairing and conducting risk management activities

Taking healthcare to a higher level

We create high-end life science devices. From design to end product, and from certification to serial production. We have been doing this for global players in the medical sector for more than 30 years. Together, we’re taking healthcare to the next level.

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