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
€229.17
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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