II.
LibrarySkill overview
Reference · livelib-skill:biomedical-engineering--iec62304-lifecycle-manager
iec62304-lifecycle-manager overview
Medical device software lifecycle management skill implementing IEC 62304 requirements
Attributes
displayName
iec62304-lifecycle-manager
description
Medical device software lifecycle management skill implementing IEC 62304 requirements
libraryPath
library/specializations/domains/science/biomedical-engineering/skills/iec62304-lifecycle-manager/SKILL.md
specialization
biomedical-engineering
contentSummary
# IEC 62304 Lifecycle Manager Skill
## Purpose
The IEC 62304 Lifecycle Manager Skill supports medical device software lifecycle management per IEC 62304, ensuring proper classification, documentation, and maintenance of software as a medical device (SaMD) and software in medical devices (SiMD)
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:compliance-automation·SkillAreaCompliance Automation
- skill-area:python-data-pipelines·SkillAreaPython Data Pipelines
Incoming edges
None.