software as a medical device (SaMD)
GPTKB entity
Statements (47)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:software
medical device |
| gptkbp:canBe |
gptkb:cloud_service
gptkb:mobile_application standalone software embedded software over-the-counter software prescription software used by caregivers used by healthcare professionals used by patients used in chronic disease management used in clinical trials used in mental health applications used in remote monitoring |
| gptkbp:definedIn |
gptkb:IMDRF
|
| gptkbp:example |
digital therapeutics
AI-based diagnostic tool clinical decision support software |
| gptkbp:excludes |
hardware medical devices
|
| https://www.w3.org/2000/01/rdf-schema#label |
software as a medical device (SaMD)
|
| gptkbp:regulates |
gptkb:FDA
gptkb:European_Medicines_Agency gptkb:MHRA gptkb:Health_Canada gptkb:International_Medical_Device_Regulators_Forum |
| gptkbp:relatedTo |
gptkb:insurance
gptkb:eHealth telemedicine |
| gptkbp:requires |
clinical evaluation
labeling regulatory approval cybersecurity measures user training quality management system |
| gptkbp:subject |
gptkb:HIPAA
gptkb:IEC_62304 gptkb:ISO_13485 gptkb:GDPR post-market surveillance risk classification |
| gptkbp:usedFor |
gptkb:psychotherapy
diagnosis monitoring prevention of disease |
| gptkbp:bfsParent |
gptkb:IEC_62304
|
| gptkbp:bfsLayer |
6
|