ra-qm-skills
Router for regulatory and quality skills: ISO 13485, MDR, FDA, ISO 14971, CAPA, ISO 27001, ISO 42001, EU AI Act, GDPR, SOC 2. Use whenever a compliance request fits no single one.
Target: Target not categorized. Automatically collected · unverified.
Excerpt from the author’s documentation
Extracted from a fixed version of SKILL.md in its original language. This is the author’s documentation; installation, compatibility and runtime results have not been verified by this site.
Read the original English text
Topics in the source
- 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
This is an excerpt. Refer to the complete source and its current requirements.
- Source repository
- alirezarezvani/claude-skills
- Source file
- ra-qm-team/skills/ra-qm-skills/SKILL.md
- Fixed revision
- 8f082544116fc0d014188e521ca40304cdfc86b0
Requirements
- Only the author’s Skill metadata is included. Read the full instructions to check dependencies, licensing and conditions of use.
A small first task
先阅读原作者说明，再决定是否在自己的 AI 工具中使用。
Instructions for your AI tool
- Claude Desktop: resource-specific guide not available yet
- Claude Code: resource-specific guide not available yet
- Cursor: resource-specific guide not available yet
- Codex: resource-specific guide not available yet
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Sources and evidence
This record was collected automatically. Its documentation, suitability and runtime behavior have not been manually verified.
Author: alirezarezvani/claude-skills · original repository metadata. Documentation review: Not reviewed. Last source check: 2026-11-09T14:01:47.519Z.
Categories are inferred from names, descriptions and paths. They do not establish compatibility.
License and attribution
MIT. Third-party content and copyright remain with their authors. Refer to the original license and terms.
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Limitations and notes
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