Medicine | Pharmacy |Non Active Medical Devices Technical unit 3.4 at a glance

Focus of the technical unit

The focus of this technical unit is on the accreditation of testing laboratories in accordance with DIN EN ISO/IEC 17025 in the areas of non-active medical devices, pharmaceuticals and active ingredients and health care. The latter area includes hospital hygiene and infection prevention, nucleic acid analysis, medical laboratory examinations within the framework of clinical studies, and occupational and environmental medicine.

In addition, this technical unit also covers biobanks in the medical environment, which are accredited in accordance with DIN EN ISO 20387, and the accreditation of management systems in accordance with DIN EN ISO 17021-1 in the area of non-active medical devices (DIN EN ISO 13485).

In accordance with the requirements of the German Accreditation Body Act, this technical unit works closely together with the Central Authority of the Federal States for Health Protection (ZLG) with regard to medicinal products and medical devices.

Accreditation promotes confidence and confirms the competence of the accredited bodies. This facilitates cooperation and national/international comparison.

Contact

Andrea Gabler

Head of Technical Unit Medicine | Pharmacy | Non Active Medical Devices

Dr. Birgit Gisela Löffler

Principal Expert Medical Devices

Dr. Nina Rählert

Principal Expert Biobanks

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