NA 063

DIN Standards Committee Medicine

Draft standard

DIN EN ISO 13485/A1
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019

Title (German)

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016); Deutsche und Englische Fassung EN ISO 13485:2016/prA1:2019

Responsible national committee

NA 063-01-13 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 2019-11
Original language German, English
Price from 117.76 €
Table of contents

Contact

Dipl.-Biol.

Annett Müller

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13627 Berlin

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