CEI UNI EN/ISO 13485:2016-04
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical devices - Quality management systems - Requirements for regulatory purposes
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
01-04-2016
Publisher
Superseded date
15-07-2025
Superseded by
Including GST 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Superseded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