CEI UNI EN/ISO 13485:2016-04
Superseded
Superseded
View Superseded by
Medical devices - Quality management systems - Requirements for regulatory purposes
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
04-01-2016
Publisher
Superseded date
07-15-2025
Superseded by
Excluding Tax where applicable
This standard specifies requirements for quality management systems that enable an organization to demonstrate its ability to provide medical devices and related services that comply with customer requirements and applicable regulatory requirements for such medical devices.
| Committee |
CT 62
|
| DocumentType |
Standard
|
| Pages |
72
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 13485:2016 | Identical |
| EN ISO 13485:2016 | Identical |
Summarise