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SS-EN ISO 13485:2016

Current
Current

The latest, up-to-date edition.

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Available format(s)

Hardcopy

Language(s)

Swedish - English

Published date

03-07-2016

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Committee
TC 210
DocumentType
Standard
Pages
0
PublisherName
Standardiserings-Kommissionen I Sverige
Status
Current

Standards Relationship
ISO 13485:2016 Identical
EN ISO 13485:2016 Identical

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