UNI CEI EN ISO 13485:2021
Current
Current
The latest, up-to-date edition.
Medical devices - Quality management systems - Requirements for regulatory purposes
Published date
18-11-2021
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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.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 13485:2016 | Identical |
| EN ISO 13485:2016 | Identical |
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