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gptkbp:instanceOf
|
gptkb:standard
|
|
gptkbp:appliesTo
|
medical device manufacturers
medical device suppliers
|
|
gptkbp:basisFor
|
regulatory compliance in medical device industry
|
|
gptkbp:category
|
medical devices
quality management
|
|
gptkbp:focusesOn
|
manual
regulatory requirements
risk management
customer satisfaction
traceability
product safety
process validation
|
|
gptkbp:fullTitle
|
gptkb:Medical_devices_—_Quality_management_systems_—_Requirements_for_regulatory_purposes
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
ISO 13485:2016
|
|
gptkbp:language
|
gptkb:French
English
other languages
|
|
gptkbp:partOf
|
gptkb:ISO_13485_family
|
|
gptkbp:publicationYear
|
2016
|
|
gptkbp:publishedBy
|
gptkb:International_Organization_for_Standardization
|
|
gptkbp:recognizedBy
|
gptkb:US_FDA
gptkb:European_Union
gptkb:Health_Canada
|
|
gptkbp:relatedTo
|
gptkb:ISO_9001
|
|
gptkbp:replacedBy
|
gptkb:ISO_13485:2003
|
|
gptkbp:scope
|
quality management systems for medical devices
|
|
gptkbp:status
|
active
|
|
gptkbp:usedBy
|
medical device companies worldwide
|
|
gptkbp:usedFor
|
certification of quality management systems
|
|
gptkbp:website
|
https://www.iso.org/standard/59752.html
|
|
gptkbp:bfsParent
|
gptkb:ISO_13485
|
|
gptkbp:bfsLayer
|
6
|