software as a medical device (SaMD)

URI: https://gptkb.org/entity/software_as_a_medical_device_(SaMD)
GPTKB entity
Statements (47)
Predicate Object
gptkbp:instanceOf gptkb:medical_device
gptkb:software
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 gptkb:clinical_decision_support_software
digital therapeutics
AI-based diagnostic tool
gptkbp:excludes hardware medical devices
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 gptkb:regulatory_approval
clinical evaluation
labeling
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:diagnosis
gptkb:psychotherapy
monitoring
prevention of disease
gptkbp:bfsParent gptkb:IEC_62304
gptkbp:bfsLayer 6
https://www.w3.org/2000/01/rdf-schema#label software as a medical device (SaMD)