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ANSI/AAMI/ISO 13485:2016(R2019)

Current

Current

The latest, up-to-date edition.

Medical devices—Quality management systems— Requirements for regulatory purposes

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

17-10-2019

€246.76
Excluding VAT

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
ISBN
1-57020-604-7
Pages
50
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

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