II.
LibraryProcess overview
Reference · livelib-process:biomedical-engineering--aiml-medical-device
aiml-medical-device overview
AI/ML Medical Device Development - Develop and validate AI/ML-based medical devices following FDA's AI/ML framework and Good Machine Learning Practice (GMLP) principles.
Attributes
displayName
aiml-medical-device
description
AI/ML Medical Device Development - Develop and validate AI/ML-based medical devices following
FDA's AI/ML framework and Good Machine Learning Practice (GMLP) principles.
libraryPath
library/specializations/domains/science/biomedical-engineering/aiml-medical-device.js
specialization
biomedical-engineering
references
- - FDA AI/ML-Based Software as a Medical Device (SaMD) Action Plan - GMLP Guiding Principles: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles - FDA Predetermined Change Control Plan Guidance
example
const result = await orchestrate('specializations/domains/science/biomedical-engineering/aiml-medical-device', {
deviceName: 'Diabetic Retinopathy Screening AI',
mlProblemType: 'Image Classification',
intendedUse: 'Automated detection of diabetic retinopathy from fundus images',
dataDescription: { dataType: 'Fundus photographs', dataSize: '100000 images' }
});
usesAgents
- general-purpose
Outgoing edges
lib_applies_to_domain1
- domain:biomedical-engineering·DomainBiomedical Engineering
lib_belongs_to_specialization1
- specialization:biomedical-engineering·SpecializationBiomedical Engineering
lib_implements_workflow2
- workflow:experiment-design·WorkflowExperiment Design
- workflow:peer-review-cycle·WorkflowPeer Review Cycle
lib_involves_role2
- role:biomedical-engineer·RoleBiomedical Engineer
- role:research-engineer·RoleResearch Engineer
lib_requires_skill_area3
- skill-area:data-analysis·SkillAreaData Analysis
- skill-area:sensor-fusion·SkillAreaSensor Fusion
- skill-area:statistical-analysis·SkillAreaStatistical Analysis
Incoming edges
None.