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.