CLAUDE

Regulatory Affairs & Quality Management Skills - Claude Code Guidance

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# Regulatory Affairs & Quality Management Skills - Claude Code Guidance

This guide covers the 12 production-ready RA/QM compliance skills for HealthTech/MedTech companies.

## RA/QM Skills Overview

**Strategic Leadership (2 skills):**
- regulatory-affairs-head - RA strategy, regulatory intelligence, authority relations
- quality-manager-qmr - QMS oversight, management review, quality culture

**Quality Systems (3 skills):**
- quality-manager-qms-iso13485 - ISO 13485 compliance, process managem
How to Use

Recommended: Install to project (local)

mkdir -p .claude/skills
curl -o .claude/skills/CLAUDE.md \
  https://raw.githubusercontent.com/alirezarezvani/claude-skills/main/ra-qm-team/CLAUDE.md

Skill is scoped to this project only. Add .claude/skills/ to your .gitignoreif you don't want to commit it.

Alternative: Clone full repo

git clone https://github.com/alirezarezvani/claude-skills

Then reference at ra-qm-team/CLAUDE.md

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