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Standards [CURRENT]

DIN EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021

Title (German)

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016); Deutsche Fassung EN ISO 13485:2016 + AC:2018 + A11:2021

Document: references other documents

Document: referenced in 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  

Edition 2021-12
Original language German
Translation English
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Table of contents

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