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.

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  Translation  Scope  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  Scope  Normative Background ISO 17664

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

Certificate