Statements (33)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:standard
|
| gptkbp:appliesTo |
medical devices
|
| gptkbp:basisFor |
gptkb:MDSAP
gptkb:CE_marking Health Canada medical device licensing |
| gptkbp:category |
medical devices
quality management |
| gptkbp:distinctFrom |
gptkb:ISO_9001
|
| gptkbp:firstPublished |
1996
|
| gptkbp:focusesOn |
quality management systems
|
| https://www.w3.org/2000/01/rdf-schema#label |
ISO 13485
|
| gptkbp:includesRequirementsFor |
gptkb:legislation
manual risk management traceability design control |
| gptkbp:language |
gptkb:French
gptkb:Russian English |
| gptkbp:latestReleaseVersion |
gptkb:ISO_13485:2016
2016-03-01 |
| gptkbp:publishedBy |
gptkb:International_Organization_for_Standardization
|
| gptkbp:referenceNumber |
gptkb:ISO_13485
|
| gptkbp:relatedTo |
gptkb:ISO_9001
|
| gptkbp:scope |
organizations involved in the life-cycle of medical devices
|
| gptkbp:status |
active
|
| gptkbp:usedBy |
service providers
suppliers medical device manufacturers |
| gptkbp:usedFor |
gptkb:legislation
|
| gptkbp:bfsParent |
gptkb:ISO
gptkb:ISO_standards |
| gptkbp:bfsLayer |
5
|