Health and care services
DIN EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015); German and English version prEN ISO 13485:2015
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO/DIS 13485:2015); Deutsche und Englische Fassung prEN ISO 13485:2015
Document: referenced in other documents
Responsible national committee
NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices
Responsible european committee
CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices
Responsible international committee
ISO/TC 210/WG 1 - Application of quality systems to medical devices