II.
LibraryProcess overview
Reference · livelib-process:biomedical-engineering--software-verification-validation
software-verification-validation overview
Medical Device Software V&V - Conduct comprehensive software verification and validation ensuring medical device software meets specified requirements and intended use per IEC 62304 and FDA guidance.
Attributes
displayName
software-verification-validation
description
Medical Device Software V&V - Conduct comprehensive software verification and validation
ensuring medical device software meets specified requirements and intended use per IEC 62304 and FDA guidance.
libraryPath
library/specializations/domains/science/biomedical-engineering/software-verification-validation.js
specialization
biomedical-engineering
references
- - IEC 62304:2006/AMD1:2015 Software Verification (Section 5.7) - FDA General Principles of Software Validation - GAMP 5 Guide for Validation of Automated Systems
example
const result = await orchestrate('specializations/domains/science/biomedical-engineering/software-verification-validation', {
softwareName: 'Infusion Pump Controller Software',
safetyClass: 'Class C',
softwareRequirements: [{ id: 'SRS-001', requirement: 'Calculate dose rate', priority: 'critical' }],
testStrategy: 'Risk-based'
});
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.