Medical devices hygiene & in-vitro toxicity

Medical devices are essential products for patient care. Due to their application in and on the body, there are high requirements from a hygienic-microbiological point of view. These requirements are constantly increasing and are anchored above all in the EU Medical Devices Regulation. We support you with high-quality and individually tailored laboratory services so that you can meet these requirements. Our laboratories are accredited for the testing of medical devices by the DAkkS according to DIN EN ISO/IEC 17025 and GLP certified. 

Dr. Kerstin Walendy-Gnirß Director of Scientific Services
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Laboratory services

For medical device manufacturers, we offer a broad service catalog that includes preservation stress testing as well as microbiological control of environmental conditions, e.g., of surfaces or the air. With our extensive know-how, we validate manual and mechanical reprocessing processes for reusable medical devices within the framework of ISO 17664-1 and -2. We test the efficacy of your disinfectants, e.g., according to EN 14561/2/3 and EN 17111, as well as your cleaning agents, but also antimicrobial wound treatment products. We also test the biocompatibility of your products according to ISO 10993-5 and ISO 10993-23, among others.   

For the necessary test procedures we are of course accredited by the DAkkS according to DIN EN ISO/IEC 17025 as well as GLP-certified (link to certificates). 

Our certications

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