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Quality

DIN EN ISO/IEC 17025, Medical Device Regulation (MDR), GLP

Quality is the basis of our services, and an essential factor to inspire your confidence in our work.

GBA Medical Device Services is accredited (with ILAC Mutual Recognition Arrangement) for biological and microbiological and hygiene testing under DIN EN ISO/IEC 17025 (for medical devices) by the Deutsche Akkreditierungsstelle (German Accreditation Body) (DAkkS, D-PL-13392-01)

Certificate DIN EN ISO/IEC 17025

Translation DIN EN ISO/IEC 17025

Scope DIN EN ISO/IEC 17025

Normative Background ISO 17664

and recognized (art. 18 MPDG, with assumption of conformity) with additional consideration of regulation 2017/745/EU (MDR) by the Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (Central Authority of the German Länder for Health Protection with regard to Medicinal Products and Medical Devices) (ZLG, ZLG-PL-MDR.013.21).

Certificate 2017/745/EU (MDR)

Scope 2017/745/EU (MDR)

Normative Background ISO 17664

GBA Medical Device Services is GLP (Good Laboratory Practice) certified by the Bayerische Überwachungsbehörde (Bavarian supervisory authority)

Certificate GLP

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