Individual skill
iso-standards-compliance-checker
Medical device standards compliance verification skill for ISO 13485, ISO 14971, IEC 62304, IEC 60601, and related standards
library/specializations/domains/science/biomedical-engineering/skills/iso-standards-compliance-checker/SKILL.md
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- Last checked
- Nov 3, 2026
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- License
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SKILL.mdcore · 3,340 bytes
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# 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.
## Capabilities
- Standards applicability determination
- Compliance checklist generation
- Gap analysis against standard clauses
- Evidence mapping to requirements
- Harmonized standards cross-reference
- Declaration of Conformity assistance