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Standards [CURRENT]

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

Edition 2016-03

Original language English

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Dipl.-Ing.

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