Karlsruhe: Animal-free biocompatibility tests of medical devices - Successful re-accreditation according to ISO 17025: 2018
On December 18, 2019, TentaMedix GmbH received the official certificate of recognition from the ZLG and the listing as an officially recognized testing laboratory for medical devices in accordance with the guidelines of 93/42 EEC, 90/385 / EEC and DIN ISO / IEC 17025 for biological and microbiological tests from Medical devices. In this context, the successful re-accreditation according to ISO 17025-2018 by the DAkkS took place.
Dr. Dominik Herzog (Managing Director): "We are proud that we were able to successfully complete the accreditation and recognition process in 2019 and are now considered a recognized testing laboratory in accordance with the specifications of the Central Office for Health Protection of Drugs and Medical Devices (ZLG) and also successfully of the DAkks are re-accredited according to ISO 17025: 2018. The biological safety of medical devices is an important issue for manufacturers and for patient safety. "
“We have invested a lot of energy and passion in accrediting our methods for biocompatibility and microbiology and having them recognized by the ZLG. Our focus was and is clearly on in-vitro- based test procedures so that no animal tests have to be carried out as part of the safety testing of medical products. " adds TentaMedix authorized signatory Dr. Wolfgang Rudy.
TentaMedix GmbH offers a wide range of ISO 17025 accredited and ZLG recognized test methods for biocompatibility testing in accordance with ISO 10993 for medical devices. Our services include tests for genotoxicity, cytotoxicity, in-vitro irritation and sensitization, in-vitro pyrogen testing (LAL and MAT), as well as the microbiological determination of sterility and microbial contamination (bioburden). Together with our sister companies in the Tentamus network, we can also offer hemocompatibility tests and chemical test methods.
“We look forward to being able to offer our customers in the medical device industry an almost complete portfolio of ISO 10993-listed in-vitro test methods with immediate effect. Especially since the new EU MDR directive will come into effect this May and thus expanded capacities from recognized laboratories are required, ”adds Dr. Dominik Herzog.
Your contact person:
Name: Dr. Dominik Herzog
executive Director
Tel. +49 174 159 13 40
Email: dominik.herzog@tentamedix.com
Name: Dr. Wolfgang Rudy
Authorized signatory
Tel. +49 721 941 52 13
Email: wolfgang.rudy@tentamedix.com
