AS ISO 13485:2017
Current
Current
The latest, up-to-date edition.
Medical devices - Quality management systems - Requirements for regulatory processes
Available format(s)
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English
Published date
12-14-2017
Publisher
Adopts ISO 13485:2016 to specify 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.
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