Standards
[CURRENT]
ISO 13485
ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes
Title (German)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke
Responsible national committee
NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices
Responsible international committee
ISO/TC 210/WG 1 - Application of quality systems to medical devices