CEI UNI EN ISO 13485:2023-01
Current
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/FDIS 13485)
Hardcopy , PDF
Italian
01-01-2023
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
|
| Pages |
62
|
| ProductNote |
This standard is also Identical to EN ISO 13485/A11:2021
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 13485:2016 | Identical |
| EN ISO 13485:2016 | Identical |
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