Medical devices — Quality management systems — Requirements for regulatory purposes
GPTKB entity
Statements (19)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:International_Standard
|
| gptkbp:alsoKnownAs |
gptkb:ISO_13485
|
| gptkbp:appliesTo |
Manufacturers of medical devices
Suppliers of medical devices |
| gptkbp:basisFor |
Quality management system certification
|
| gptkbp:field |
Medical devices
Quality management |
| gptkbp:firstPublished |
1996
|
| https://www.w3.org/2000/01/rdf-schema#label |
Medical devices — Quality management systems — Requirements for regulatory purposes
|
| gptkbp:language |
gptkb:French
English |
| gptkbp:latestReleaseVersion |
gptkb:ISO_13485:2016
|
| gptkbp:publishedBy |
gptkb:International_Organization_for_Standardization
|
| gptkbp:purpose |
Regulatory compliance
|
| gptkbp:relatedTo |
gptkb:ISO_9001
|
| gptkbp:standardNumber |
gptkb:ISO_13485
|
| gptkbp:status |
Active
|
| gptkbp:bfsParent |
gptkb:ISO_13485:2016
|
| gptkbp:bfsLayer |
7
|