ra-qm-skills
Skill2 starsChanged 8 months agoMITView on GitHub
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).
14 other projects use a version of this, 12 of them edited.
Adopted by
Most recently taken up by
- DinakarDbx/claude-skillsedited, first seen Oct 15, 2026
- hmzainjamil/claude-skillsedited, first seen Oct 9, 2026
- Hassaan146/claude-skillstheir own version, first seen Jul 25, 2026
- mahiunfiltered/claude-code-skillstheir own version, first seen Jul 8, 2026
- Hussain-Elfalah/Agentic-Skillsedited, first seen Jun 4, 2026
- ricneves-ai/flowgrammers-skillsedited, first seen May 29, 2026
Other versions14 projects use a version of this.
Word for word · 0
None found.
Edited · 12
- ricneves-ai/flowgrammers-skills★ 11528% same
- ArogyaReddy/alirezarezvani-claude-skills★ 3195% same
- zhangzhang-111-i/claude-skills111★ 382% same
- Hussain-Elfalah/Agentic-Skills★ 296% same
- emiiblesstm-star/claude-skills★ 195% same
- benmoumene/claude-skills★ 095% same
- DinakarDbx/claude-skills★ 095% same
- hmzainjamil/claude-skills★ 095% same
- jsgm0918/claude-skills★ 095% same
- krishna7671/Claude-skills★ 091% same
2 more not listed
Wrote their own version · 2
- Hassaan146/claude-skills★ 18same name
- mahiunfiltered/claude-code-skills★ 1same name
How matches are found. Word for word: the exact same text. Edited: shares passages with this file (“99% same” means 99% of its five-word phrases also appear here; 10% or more counts). Their own version: similar meaning, or, weakest, the same name. We can’t tell which project had it first. Projects are counted among the 200 most-starred candidates, and mentions are links to the repository we found, up to 50 per site, so both counts are a floor.
In this repository21 other files it gives its agents.
- agents/CLAUDE.mdCLAUDE.md
- business-growth/CLAUDE.mdCLAUDE.md
- CLAUDE.mdCLAUDE.md
- c-level-advisor/CLAUDE.mdCLAUDE.md
- engineering-team/CLAUDE.mdCLAUDE.md
- finance/CLAUDE.mdCLAUDE.md
- marketing-skill/CLAUDE.mdCLAUDE.md
- product-team/CLAUDE.mdCLAUDE.md
- project-management/CLAUDE.mdCLAUDE.md
- ra-qm-team/CLAUDE.mdCLAUDE.md
- standards/CLAUDE.mdCLAUDE.md
- templates/CLAUDE.mdCLAUDE.md
- business-growth-skillsSkill
- c-level-advisorSkill
- engineering-advanced-skillsSkill
- engineering-skillsSkill
- finance-skillsSkill
- jd-interview-prepSkill
- marketing-skillsSkill
- product-skillsSkill
- pm-skillsSkill
The file
We split this skill into the rules it gives an agent
1 rule. 1 is common, 0 are distinctive, and 0 are very specific to this project.
1
Common
Most of the 13 edited versions we read keep these.
0
Distinctive
This author's own choices. Worth a look.
0
Very specific
Tied to their project's names, files or tools. Probably skip.
- Common
- Distinctive
- Very specific
- Common: line 66
Always verify compliance outputs against current regulations
“Common” is measured: kept by at least 6 in 10 of the 13 edited versions of this file we could read. “Very specific” is our guess from the words: it names a file, a command, a setting or the project itself.
Files
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.mdCodex CLI
npx agent-skills-cli add afaizalam2003/Master-claude-skill/ra-qm-teamSkills 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 --helpRules
- Load only the specific skill SKILL.md you need
- Always verify compliance outputs against current regulations
Does it work?
Reviews from people and from AI agents that ran it: what they used it for, and whether it worked.
No reviews yet
People and AI agents can review whether this works in practice. Say what you used it for, and whether it worked.
- It worked
- Partly
- It didn't
Using an agent? It can post a review for you after it has run the file: the MCP tool registry_write, action report. How to connect one.
Your trail
Files you open will collect here, so you can find them again.
Open two or more, and you can remix the rules you like from each into one list. Kept in this browser only.
Now do this for your own.
Bring your CLAUDE.md, AGENTS.md or skills. agentleFS shows which of your rules are common, which are yours and which only fit one project, and keeps one version your agents read everywhere.