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SN EN ISO 13485:2016

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Current

The latest, up-to-date edition.

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES (ISO 13485:2016)
Available format(s)

Hardcopy

Published date

03-01-2016

ISO 13485:2016 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
INB/NK 410
DevelopmentNote
Supersedes SN EN ISO 13488. (09/2004) Supersedes SN EN 46003. (11/2007)
DocumentType
Standard
Pages
0
PublisherName
Swiss Standards
Status
Current

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