Medical devices

Medical devices

Medical devices are essential products for patient care. Due to their application area at and on the body they have to fulfill highest requirements in terms of hygiene and microbiology. The requirements are constantly increasing and will be tied up especially in the medical device directive. We support you comprehensively with consulting, training and laboratory services in order to fulfill these requirements. For the testing of medical devices our laboratories are accredited by the DAkkS according to DIN EN ISO/IEC 17025 and recognized by the ZLG. 

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Dear costumers

Our family-run company is always at your service. We meet you where you are, are always fair and offer high quality. We seek lasting, successful relationships in which each of us can learn from the other to the benefit of all. We constantly adapt our services to meet your needs. We look forward to hearing from you.

Kind regards,

Dr. Kerstin Walendy-Gnirß
Director of Scientific Services

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Laboratory services

For medical device manufacturers we offer a wide range of services that cover both microbiological quality control according to Pharm. Eur. as well as conservation load tests and microbiological control of the environmental conditions, e.g. of surfaces or air. As a special service we validate manual and mechanical reprocessing processes for reusable medical devices with our extensive know-how. We will be pleased to advise you on the interpretation of the test results. For the necessary test procedures, we are of course accredited by the DAkkS according to DIN EN ISO/IEC 17025 and recognized by the ZLG as a manufacturer-independent test laboratory for the testing of medical devices. In the following list you can get an overview. If a test procedure is missing, please do not hesitate to contact us.

disinfection
1 We are accredited for the procedures marked with an asterisk,

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