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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
Price On Request
Table of contents

Contact

Dipl.-Ing.

Margarethe Boresch

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2413
Fax: +49 30 2601-42413

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