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Medical devices must meet product-specific performance requirements and must be assessed for biocompatibility. This applies to both new approvals and changes to products already on the market.

 

We provide you with neutral proof of the efficacy and safety of your product.

 

Hohenstein is a testing laboratory accredited by the German Accreditation Body (DAkkS) for biological, chemical and physical testing of medical devices. We also offer safety tests on medical devices in compliance with the principles of GLP.

Our tests form the basis for the necessary evidence you need for your technical documentation. This is a prerequisite for your medical device to be compliant with the European Medical Device Regulation (MDR) and thus allowed to be placed on the market in Europe. With GLP-compliant tests, you meet the regulatory requirements for international markets.

 

We combine the highest technical standards with personal service: whether it's a testing strategy, individual questions or short processing times – your requirements are our focus.

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Hohenstein Medical