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Skills/alirezarezvani/claude-skills/ra-qm-skills
ra-qm-skills logo

ra-qm-skills

alirezarezvani/claude-skills
2K installs18K stars
Run it on Hostinger →up to 70% off + an extra 10% with code ZACAARON10Free API →

Installation

npx skills add https://github.com/alirezarezvani/claude-skills --skill ra-qm-skills

Summary

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).

SKILL.md

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

SkillFolderFocus
Regulatory Affairs Headregulatory-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 Specialistrisk-management-specialist/ISO 14971, FMEA, risk files
CAPA Officercapa-officer/Root cause analysis, corrective actions
Quality Documentation Managerquality-documentation-manager/Document control, 21 CFR Part 11
QMS Audit Expertqms-audit-expert/ISO 13485 internal audits
ISMS Audit Expertisms-audit-expert/ISO 27001 security audits
Information Security Managerinformation-security-manager-iso27001/ISMS implementation
MDR 745 Specialistmdr-745-specialist/EU MDR classification, CE marking
FDA Consultantfda-consultant-specialist/510(k), PMA, QSR compliance
GDPR/DSGVO Expertgdpr-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

Score

0–100
65/ 100

Grade

C

Popularity17/30

1,585 installs — growing adoption. Source repo has 18,066 GitHub stars.

Completeness27/30

Documented: full SKILL.md body, description, one-line install. Missing: category/license metadata.

Trust15/25

Community skill with a public GitHub source repository you can review.

Freshness6/15

No update timestamp is tracked for this skill in our catalog.

Scored automatically from popularity, completeness, trust, and freshness — computed only from data in our catalog, never fabricated.

Proud of your score? Add this badge to your README.

Paste a snippet into your GitHub README. The badge updates automatically and links back to this page.

Ra Qm Skills skill score badge previewScore badge

Markdown

[![Ra Qm Skills skill](https://www.remoteopenclaw.com/skills/alirezarezvani/claude-skills/ra-qm-skills/badges/score.svg)](https://www.remoteopenclaw.com/skills/alirezarezvani/claude-skills/ra-qm-skills)

HTML

<a href="https://www.remoteopenclaw.com/skills/alirezarezvani/claude-skills/ra-qm-skills"><img src="https://www.remoteopenclaw.com/skills/alirezarezvani/claude-skills/ra-qm-skills/badges/score.svg" alt="Ra Qm Skills skill"/></a>

Ra Qm Skills FAQ

How do I install the Ra Qm Skills skill?

Run “npx skills add https://github.com/alirezarezvani/claude-skills --skill ra-qm-skills” in your terminal. The skill is added to your agent's skills directory and picked up automatically on the next run — no restart or extra configuration needed.

What does the Ra Qm Skills skill do?

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). The full SKILL.md on this page shows the exact instructions the skill gives your agent.

Is the Ra Qm Skills skill free?

Yes. Ra Qm Skills is a free, open-source skill published from alirezarezvani/claude-skills. As with any third-party skill, review the source repository before installing it into an agent with sensitive access.

Does Ra Qm Skills work with Claude Code and OpenClaw?

Yes. Skills use the portable SKILL.md format, so Ra Qm Skills works with Claude Code, OpenClaw, Codex, Hermes, and any other agent that reads SKILL.md skills.

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