DIN Standards Committee Health Technologies
DIN EN ISO 13485 Berichtigung 1
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016, Corrigendum to DIN EN ISO 13485:2016-08; German version EN ISO 13485:2016/AC:2016
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016); Deutsche Fassung EN ISO 13485:2016, Berichtigung zu DIN EN ISO 13485:2016-08; Deutsche Fassung EN ISO 13485:2016/AC:2016
Document: references 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