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QM-System Certification

Our services in certification according to quality system standards include ISO 13485 as a special standard in the medical device and in-vitro diagnostic device sector as well as ISO 9001 certification. Besides the medical device and in-vitro diagnostic device industry we offer certification in related areas like pharmaceuticals, service companies, distributors, and crafts in healthcare.

We are one of the few European Notified Bodies, whose audits of medical device manufacturers based in Europe, are recognized under the Technical Cooperation Program (TCP) in Taiwan. Audits for medical device companies having or seeking approval in US, Canada, Australia, Brazil or Japan can be offered in cooperation with a recognized auditing organization under the Medical Device Single Audit Program (MDSAP).

Furthermore, we offer assessment and certification of health care institutions, doctors‘ offices and providers of other health care supplies according to special German requirements.