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GOST ISO 13485:2017

Current

Current

The latest, up-to-date edition.

Medical devices. Quality management systems. Requirements for regulatory purposes

Available format(s)

Hardcopy

Language(s)

English

Published date

30-06-2017

This standard establishes requirements for a quality management system in cases where an organization needs to demonstrate the ability to supply medical devices and provide related services that meet customer requirements and applicable regulatory requirements.

DocumentType
Standard
Pages
0
ProductNote
This standard also identical to GOST R 54881, GOST R 58454, GOST R 59767, GOST R 59768, GOST R 59769, GOST R 59770, GOST R 59921.5, GOST R 59921.8, GOST R 70393, GOST R 70478, GOST R ISO 11737-1
PublisherName
Interstandard (Russia)
Status
Current
Supersedes

Standards Relationship
ISO 11737-1:2018 Identical

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