CEI UNI EN ISO 13485:2022-02
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 (ISO/FDIS 13485)
01-02-2022
12-07-2025
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Superseded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 |
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