Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.
8.3
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Documentation
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Exceptional skill for ISO 13485 certification documentation. The description clearly covers all capabilities (gap analysis, document creation, requirements understanding, MDF preparation). Task knowledge is comprehensive with detailed workflows, prioritization schemes, 5 scenario-based approaches, and references to scripts/templates. Structure is excellent: concise overview followed by systematic workflows, common scenarios, best practices, and quick reference materials. The skill is highly novel—creating compliant QMS documentation requires deep regulatory expertise, understanding 31+ required procedures, proper justification of exclusions, and harmonization across FDA/EU/other regulations. A CLI agent would struggle significantly with this domain-specific complexity, making this skill extremely valuable for cost reduction and quality assurance in medical device certification.
K-Dense-AI
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