NA 176
DIN Standards Committee Health Technologies
Standards
[CURRENT]
EN ISO 13485
EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Title (German)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016)
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
