Accredited test laboratory, technical documentation, access to international markets. Everything from a single source.

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Your service provider for medical devices

Accredited test laboratory

Testing the safety of active medical devices and in vitro diagnostic (IVD) medical devices.

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Technical documentation/
Compliance Engineering

Technical documentation for CE marking of medical devices.

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Regulatory Affairs

Medical technology is a regulated market – with good reason. What requirements are set by the various authorities around the world? Our Regulatory Affairs Managers have the answers. We not only deal with the requirements for CE marking, but also with international markets such as the USA, Canada or Australia.

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Jobs

We are always looking for new KEYMKRs.

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