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SANS 13485:2018

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

13-03-2018

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 1039
DocumentType
Standard
ISBN
978-0-626-42362-9
Pages
0
PublisherName
South African Bureau of Standards
Status
Current
Supersedes

Standards Relationship
ISO 13485:2016 Identical

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$101.70
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