II.
LibraryProcess overview
Reference · livelib-process:biomedical-engineering--software-lifecycle-iec62304
software-lifecycle-iec62304 overview
Medical Device Software Development Lifecycle per IEC 62304 - Implement software development lifecycle including planning, requirements, design, implementation, verification, and maintenance.
Attributes
displayName
software-lifecycle-iec62304
description
Medical Device Software Development Lifecycle per IEC 62304 - Implement software development
lifecycle including planning, requirements, design, implementation, verification, and maintenance.
libraryPath
library/specializations/domains/science/biomedical-engineering/software-lifecycle-iec62304.js
specialization
biomedical-engineering
references
- - IEC 62304:2006/AMD1:2015 Medical device software - Software life cycle processes - FDA Guidance on General Principles of Software Validation - IEC 82304-1 Health software - General requirements for product safety
example
const result = await orchestrate('specializations/domains/science/biomedical-engineering/software-lifecycle-iec62304', {
softwareName: 'Patient Monitoring Software',
safetyClass: 'Class B',
intendedUse: 'Real-time vital signs monitoring and alarming',
developmentModel: 'Agile-with-gates'
});
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.