Karlsruhe: Animal free biomcompatibility testing of medical devices achieved ZLG recognition – Succesful Re-Accreditation according to ISO 17025:2018
On the 18th of December 2019 the Tentamus company TentaMedix GmbH received the official recognition document and listing by ZLG as testing laboratory according to the guideline 93/42 EWG, 90/385/EWG and DIN ISO/IEC 17025 for biological and microbiological testing of medical devices and successful Re-Accreditation according to ISO 17025:2018 by DAkkS.
TentaMedix’ Managing Director Dr. Dominik Herzog reports: “We are proud to have completed the auditing process successfully in 2019. We are now officially listed as an approved laboratory for medical device testing according to the specifications of the Central Authority of the federal states for Health Protection with regard to Medicinal products and Medical Devices (ZLG) and re-accredited according to ISO 17025-2018. Safety testing of medical devices is becoming a more and more important issue for the medical device industry with special regard to patient safety.”
“We put quite some effort in having our biocompatibility and microbiological testing methods accredited and in becoming a testing laboratory for medical devices. Our clear focus lies on in-vitro based testing methods so that no animal testing is needed for product safety testing of medical devices.” added TentaMedix’s procurist Dr. Wolfgang Rudy.
TentaMedix GmbH can now offer ISO 17025 accredited testing services for medical devices in the field of ISO 10993 biocompatibility testing. TentaMedix`s services ranging from genotoxicity, cytotoxicity, and in-vitro irritation, sensitization as well as pyrogen testing in combination with the microbiological testing of bioburden, sterility, and LAL testing. Together within the Tentamus laboratory network hemocompatibility and chemical testing parameters can also be performed.
“We look forward to offer an almost complete spectrum of ISO 10993 listed biocomatibility testing parameters for our clients in the medical device industry. Especially with the new EU-MDR regulation, becoming effective this May, it is essential to have more testing capacities of listed laboratories.” adds Dr. Dominik Herzog.
Name: Dr. Dominik Herzog
Tel +49 174 159 13 40
Name: Dr. Wolfgang Rudy
Tel +49 721 941 52 13