ISO 13485 Quality Management System specialist for medical device companies. Provides QMS implementation, maintenance, process optimization, and compliance expertise. Use for QMS design, documentation control, management review, internal auditing, corrective actions, and ISO 13485 certification activities.
8.1
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0
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Business & Productivity
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Excellent ISO 13485 QMS skill with comprehensive coverage of quality management processes for medical device companies. The description clearly articulates when to use this skill (QMS design, document control, auditing, CAPA, certification). Structure is well-organized with logical sections covering implementation, document control, audits, and continuous improvement. Provides detailed task knowledge including workflows, decision points, and references to scripts/templates. The skill demonstrates high novelty as ISO 13485 compliance requires specialized domain expertise that would consume significant tokens for a CLI agent to replicate. Minor room for improvement: could include more specific examples of input/output formats for key functions, and slightly more explicit guidance on skill invocation patterns for different user scenarios.
davila7
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