UNE-EN ISO 13485:2018
Current
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
Hardcopy , PDF
07-25-2018
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
75
|
| ProductNote |
THIS STANDARD ALSO REFERS TO: GHTF/SG1/N055:2009 ,GHTF/SG5/N4:2010 ,GHTF/SG1/N70:2011 ,GHTF/SG1/N071:2012.
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 13485:2016 | Identical |
| ISO 13485:2016 | Identical |
| EN ISO 13485:2016/AC:2018 | Identical |
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