NA 175
DIN Standards Committee for Organizational Processes
Draft standard
[Withdrawn]
DIN EN ISO 13485/A1
DIN EN ISO 13485/A1
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
Title (German)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016); Deutsche und Englische Fassung EN ISO 13485:2016/prA1:2019
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
