CEI UNI EN/ISO 13485:2016-04
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical devices - Quality management systems - Requirements for regulatory purposes
01-04-2016
15-07-2025
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
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 13485:2016 | Identical |
| EN ISO 13485:2016 | Identical |
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