ANSI/AAMI/ISO 13485:2016(R2019)
Current
The latest, up-to-date edition.
Medical devices—Quality management systems— Requirements for regulatory purposes
Hardcopy , PDF
English
17-10-2019
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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