II.
LibrarySkill overview
Reference · livelib-skill:biomedical-engineering--aiml-validation-framework
aiml-validation-framework overview
AI/ML medical device validation skill implementing FDA's GMLP principles
Attributes
displayName
aiml-validation-framework
description
AI/ML medical device validation skill implementing FDA's GMLP principles
libraryPath
library/specializations/domains/science/biomedical-engineering/skills/aiml-validation-framework/SKILL.md
specialization
biomedical-engineering
contentSummary
# AI/ML Validation Framework Skill
## Purpose
The AI/ML Validation Framework Skill supports validation of AI/ML-enabled medical devices per FDA Good Machine Learning Practice (GMLP) principles, addressing data quality, model performance, and predetermined change control.
## Capabilities
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:ml-engineer·RoleMachine Learning Engineer
lib_requires_skill_area3
- skill-area:machine-learning-frameworks·SkillAreaMachine Learning Frameworks
- skill-area:statistical-analysis·SkillAreaStatistical Analysis
- skill-area:compliance-automation·SkillAreaCompliance Automation
Incoming edges
None.