SS-EN ISO 13485:2016
Current
Current
The latest, up-to-date edition.
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Available format(s)
Hardcopy
Language(s)
Swedish - English
Published date
03-07-2016
Publisher
Important note : All end users must be registered with an Account prior to user licenses being assigned.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
|
| Pages |
0
|
| PublisherName |
Standardiserings-Kommissionen I Sverige
|
| Status |
Current
|
| Standards | Relationship |
| ISO 13485:2016 | Identical |
| EN ISO 13485:2016 | Identical |
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