How do I install the Ra Qm Skills skill?

Run npx skillmds@latest add comeonoliver/ra-qm-skills in your terminal (requires Node.js), paste this page's agent-chat prompt into Claude, Cursor, or any MCP-connected agent, or download the SKILL.md file and copy it into your agent's skills directory.

Is Ra Qm Skills safe to use?

This skill has not completed SkillMD's automated safety review yet. Independent scanners report: SkillSpector: PASS, Skill Scanner: PASS. Capability flags: docs only. SkillMD never runs a skill's scripts for you; review the SKILL.md before installing.

Which AI agents work with Ra Qm Skills?

This skill is tagged as working with Claude Code, Claude.ai, OpenAI Codex. SKILL.md is an open format, so most agents that read a skills directory can load it too.

Is Ra Qm Skills free to use?

Yes. Installing skills from SkillMD is free. This skill is licensed under MIT.

Who published Ra Qm Skills?

ComeOnOliver (@comeonoliver) published this skill. Their other Agent Skills are listed on their SkillMD profile.

Ra Qm Skills by comeonoliver — Agent Skill

Name: Ra Qm Skills
Rating: 4.5 (4 reviews)
Author: ComeOnOliver

Ra Qm Skills

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).

ComeOnOliver Updated Sep 8, 2026 61 repo stars

File contents

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

---name: ra-qm-skillsdescription: 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).license: MIT---# Regulatory Affairs & Quality Management Skills12 production-ready compliance skills for HealthTech and MedTech organizations.## Quick Start### Claude Code```/read ra-qm-team/regulatory-affairs-head/SKILL.md```### Codex CLI```bashnpx 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 Tools17 scripts, all stdlib-only:```bashpython3 risk-management-specialist/scripts/risk_matrix_calculator.py --helppython3 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

Frequently asked questions