CEI UNI EN ISO 13485:2022-02
Superseded
Superseded
View Superseded by
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/FDIS 13485)
Published date
02-01-2022
Publisher
Superseded date
07-12-2025
Superseded by
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This Standard specifies the requirements for quality management systems that allow an organization to demonstrate its ability to provide medical devices and related services that comply with customer requirements and applicable regulatory requirements.
| Committee |
CT 62
|
| DocumentType |
Standard
|
| ProductNote |
This standard is also Identical to EN ISO 13485/A11:2021
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 13485:2016 | Identical |
| EN ISO 13485:2016 | Identical |
Summarise
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