Statements (18)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
medical device regulatory program
|
| gptkbp:administeredBy |
gptkb:International_Medical_Device_Regulators_Forum
|
| gptkbp:appliesTo |
medical device manufacturers
|
| gptkbp:auditCovers |
ISO 13485 requirements
country-specific regulatory requirements |
| gptkbp:auditPerformedBy |
authorized auditing organizations
|
| gptkbp:fullName |
gptkb:Medical_Device_Single_Audit_Program
|
| https://www.w3.org/2000/01/rdf-schema#label |
MDSAP
|
| gptkbp:launched |
2014
|
| gptkbp:purpose |
to allow a single regulatory audit of a medical device manufacturer’s quality management system
|
| gptkbp:recognizedBy |
gptkb:Health_Canada
gptkb:Therapeutic_Goods_Administration_(Australia) gptkb:United_States_Food_and_Drug_Administration gptkb:Brazilian_Health_Regulatory_Agency_(ANVISA) gptkb:Japan_Pharmaceuticals_and_Medical_Devices_Agency |
| gptkbp:website |
https://www.fda.gov/medical-devices/cdrh-international-programs/medical-device-single-audit-program-mdsap
|
| gptkbp:bfsParent |
gptkb:ISO_13485
|
| gptkbp:bfsLayer |
6
|