---

name: "ra-qm-skills" description: "12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only)." version: 1.0.0 author: Alireza Rezvani license: MIT tags:

• regulatory
• quality-management
• iso-13485
• mdr
• fda
• iso-27001
• gdpr agents:
• claude-code
• codex-cli
• openclaw

---

Regulatory Affairs & Quality Management Skills

12 production-ready compliance skills for HealthTech and MedTech organizations.

Quick Start

Claude Code

/read ra-qm-team/regulatory-affairs-head/SKILL.md

Codex CLI

npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team

Skills Overview

Skill	Folder	Focus
Regulatory Affairs Head	regulatory-affairs-head/	FDA/MDR strategy, submissions
Quality Manager (QMR)	quality-manager-qmr/	QMS governance, management review
Quality Manager (ISO 13485)	quality-manager-qms-iso13485/	QMS implementation, doc control
Risk Management Specialist	risk-management-specialist/	ISO 14971, FMEA, risk files
CAPA Officer	capa-officer/	Root cause analysis, corrective actions
Quality Documentation Manager	quality-documentation-manager/	Document control, 21 CFR Part 11
QMS Audit Expert	qms-audit-expert/	ISO 13485 internal audits
ISMS Audit Expert	isms-audit-expert/	ISO 27001 security audits
Information Security Manager	information-security-manager-iso27001/	ISMS implementation
MDR 745 Specialist	mdr-745-specialist/	EU MDR classification, CE marking
FDA Consultant	fda-consultant-specialist/	510(k), PMA, QSR compliance
GDPR/DSGVO Expert	gdpr-dsgvo-expert/	Privacy compliance, DPIA

Python Tools

17 scripts, all stdlib-only:

python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help
python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help

Rules

• Load only the specific skill SKILL.md you need
• Always verify compliance outputs against current regulations