Your partner for international market access

Your partner for international market access

Accredited testing laboratory & technical documentation – All from a single source

Achieve CE marking for your medical device with us

We are the key to the market. We are the only service provider that creates technical documentation and risk assessments as well as carrying out product tests of safety and performance in our accredited laboratory. Experienced compliance and test engineers with specialist know-how accompany you and your product through the entire process of European CE marking or regulatory affairs for access to international markets such as the USA, Canada or Australia.

We prepare complete compliance files based on the current Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Device Regulation (IVDR) 2017/746, even during product development. With our engineers, the preparation of risk management according to DIN EN ISO 14971 or complete tests in our test laboratory according to IEC / DIN EN 60601-1 and IEC / DIN EN 61010 are in the best of hands.

Entered into Force: The New Transition Periods of the IVDR

What else is changing with Regulation (EU) 2024/160? We’ve summarized all key content, timelines, changes, and NEW transition periods in a compact format.

Learn more about IVDR

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With us, your medical products are in the best of hands.

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The KEYMKR, our KEYhistory and founding objective.

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We are always looking for new KEYMKRs.

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How can we help?

We have the necessary expertise and years of experience for the successful development of medical devices.

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