II.
LibrarySkill overview
Reference · livelib-skill:biomedical-engineering--iso14971-risk-analyzer
iso14971-risk-analyzer overview
Comprehensive risk management skill implementing ISO 14971:2019 methodology for medical device risk analysis
Attributes
displayName
iso14971-risk-analyzer
description
Comprehensive risk management skill implementing ISO 14971:2019 methodology for medical device risk analysis
libraryPath
library/specializations/domains/science/biomedical-engineering/skills/iso14971-risk-analyzer/SKILL.md
specialization
biomedical-engineering
contentSummary
# ISO 14971 Risk Analyzer Skill
## Purpose
The ISO 14971 Risk Analyzer Skill implements comprehensive risk management methodology per ISO 14971:2019 for medical devices, supporting hazard identification, risk estimation, risk control, and benefit-risk analysis throughout the device lifecycle.
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:statistical-analysis·SkillAreaStatistical Analysis
- skill-area:data-analysis·SkillAreaData Analysis
- skill-area:compliance-automation·SkillAreaCompliance Automation
Incoming edges
None.