Quality of our services

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 Acrobat_icon Translation Acrobat_icon Scope Acrobat_icon Normative Background ISO 17664 Acrobat_icon

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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 Acrobat_icon Scope Acrobat_icon Normative Background ISO 17664 Acrobat_icon

ZLG_PL_MDR_013_21

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

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GLP-Verlauf-4