II.
LibrarySkill overview
Reference · livelib-skill:biomedical-engineering--iso-standards-compliance-checker
iso-standards-compliance-checker overview
Medical device standards compliance verification skill for ISO 13485, ISO 14971, IEC 62304, IEC 60601, and related standards
Attributes
displayName
iso-standards-compliance-checker
description
Medical device standards compliance verification skill for ISO 13485, ISO 14971, IEC 62304, IEC 60601, and related standards
libraryPath
library/specializations/domains/science/biomedical-engineering/skills/iso-standards-compliance-checker/SKILL.md
specialization
biomedical-engineering
contentSummary
# ISO Standards Compliance Checker Skill
## Purpose
The ISO Standards Compliance Checker Skill verifies medical device compliance with applicable ISO and IEC standards, generating compliance checklists, gap analyses, and evidence mapping for quality management and regulatory submissions.
##
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:compliance-engineer·RoleCompliance Engineer
lib_requires_skill_area3
- skill-area:data-analysis·SkillAreaData Analysis
- skill-area:compliance-automation·SkillAreaCompliance Automation
- skill-area:statistical-analysis·SkillAreaStatistical Analysis
Incoming edges
None.