Ra Qm Skills
- 1.6k installs
- 23.5k repo stars
- Updated July 17, 2026
- alirezarezvani/claude-skills
ra-qm-skills is an agent skill that 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, G.
About
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 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 2 9 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 bash 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 implementatio.
- Regulatory Affairs & Quality Management Skills
- Load only the specific skill SKILL.md you need
- Always verify compliance outputs against current regulations
- --- name: "ra-qm-skills" description: "12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, C
- ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document con
Ra Qm Skills by the numbers
- 1,634 all-time installs (skills.sh)
- +2 installs in the week ending Jul 29, 2026 (Skillselion tracking)
- Ranked #315 of 2,203 Security skills by installs in the Skillselion catalog
- Security screen: MEDIUM risk (skills.sh audit)
- Data as of Jul 31, 2026 (Skillselion catalog sync)
ra-qm-skills capabilities & compatibility
- Capabilities
- regulatory affairs & quality management skills · load only the specific skill skill.md you need · always verify compliance outputs against current · name: "ra qm skills" description: "12 regula · iso 13485 qms, mdr 2017/745, fda 510(k)/pma, iso
- Use cases
- documentation
What ra-qm-skills says it does
--- 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.
npx skills add https://github.com/alirezarezvani/claude-skills --skill ra-qm-skillsAdd your badge
Show developers this skill is listed on Skillselion. Paste this into your README.
| Installs | 1.6k |
|---|---|
| repo stars | ★ 23.5k |
| Security audit | 3 / 3 scanners passed |
| Last updated | July 17, 2026 |
| Repository | alirezarezvani/claude-skills ↗ |
What problem does ra-qm-skills solve for developers using this skill?
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),
Who is it for?
Developers who need ra-qm-skills patterns described in the cached skill documentation.
Skip if: Skip when docs are empty or the task is outside the skill's documented scope.
When should I use this skill?
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),
What you get
Actionable workflows and conventions from SKILL.md for ra-qm-skills.
- Compliance guardrail prompts
- CAPA workflow guidance
- Risk-management checklists
By the numbers
- 12 production-ready regulatory and QM agent skills
- Version 2.9.0 under MIT license
- Python tools use stdlib only
Files
../../../ra-qm-team/skills/ra-qm-skills/SKILL.md
Related skills
Entra App RegistrationCorrectly register an application in Microsoft Entra ID, configure OAuth 2.0 flows, request the right API permissions, and generate working MSAL authentication snippets476k1.3kAzure ComplianceRun automated Azure compliance scans, security posture checks, and Key Vault expiration audits before deploying.475k1.3k
Openclaw Secure Linux CloudDeploy and harden an OpenClaw agent instance on a Linux cloud server following battle-tested security defaults.270k72
Better Auth Best PracticesCorrectly configure Better Auth for secure authentication with database adapters, sessions, OAuth, email/password, and plugins in TypeScript projects.78.9k204
Firebase Security Rules AuditorAutomatically audit Firebase Firestore security rules for bypass vulnerabilities and logic gaps before deploying.77.7k388
Audit WebsiteRun comprehensive audits that surface SEO, performance, security, technical, and content issues with LLM-optimized reports and health scores.64.9k85How it compares
Use ra-qm-skills for MedTech-specific ISO and FDA frameworks instead of generic security audit skills lacking QMS and MDR coverage.
FAQ
What does ra-qm-skills 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 contr
When should I use 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 contr
Is ra-qm-skills safe to install?
Review the Security Audits panel on this page before installing in production.