ra-qm-skills

原文涵盖的主题

• Regulatory Affairs & Quality Management Skills — Router
• Routing table
• Quick start
• Rules

This plugin bundles 15 compliance skills for HealthTech/MedTech organizations (this router is the 16th folder under ra-qm-team/skills/). Each skill is self-contained. Match the request, then load ra-qm-team/skills/ /SKILL.md. If multiple rows match, ask one clarifying question first. | Request signals | Skill | Path | |---|---|---| | Regulatory strategy, pathway selection, submissions planning | regulatory-affairs-head | skills/regulatory-affairs-head/ | | Management review, quality KPIs, QMR governance | quality-manager-qmr | skills/quality-manager-qmr/ | | ISO 13485 QMS implementation, process control | quality-manager-qms-iso13485 | skills/quality-manager-qms-iso13485/ | | ISO 14971 risk analysis, FMEA, risk files | risk-management-specialist | skills/risk-management-specialist/ | | Root cause analysis, corrective/preventive actions | capa-officer | skills/capa-officer/ | | Document control, 21 CFR Part 11, DHF/DMR/DHR | quality-documentation-manager | skills/quality-documentation-manager/ | | ISO 13485 internal audits, NC classification | qms-audit-expert | skills/qms-audit-expert/ | | ISO 27001 audit planning and execution | isms-audit-expert | skills/isms-audit-expert/ | | IS

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