DIN Standards Committee Health Technologies
DIN EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2003 + Cor. 1:2009); Deutsche Fassung EN ISO 13485:2003 + AC:2009
Document: references other documents
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