ra-qm-skills▌
alirezarezvani/claude-skills · updated Apr 8, 2026
12 production-ready compliance skills for HealthTech and MedTech organizations.
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
Ratings
4.5★★★★★10 reviews- ★★★★★Shikha Mishra· Oct 10, 2024
ra-qm-skills is among the better-maintained entries we tried; worth keeping pinned for repeat workflows.
- ★★★★★Piyush G· Sep 9, 2024
Keeps context tight: ra-qm-skills is the kind of skill you can hand to a new teammate without a long onboarding doc.
- ★★★★★Chaitanya Patil· Aug 8, 2024
Registry listing for ra-qm-skills matched our evaluation — installs cleanly and behaves as described in the markdown.
- ★★★★★Sakshi Patil· Jul 7, 2024
ra-qm-skills reduced setup friction for our internal harness; good balance of opinion and flexibility.
- ★★★★★Ganesh Mohane· Jun 6, 2024
I recommend ra-qm-skills for anyone iterating fast on agent tooling; clear intent and a small, reviewable surface area.
- ★★★★★Oshnikdeep· May 5, 2024
Useful defaults in ra-qm-skills — fewer surprises than typical one-off scripts, and it plays nicely with `npx skills` flows.
- ★★★★★Dhruvi Jain· Apr 4, 2024
ra-qm-skills has been reliable in day-to-day use. Documentation quality is above average for community skills.
- ★★★★★Rahul Santra· Mar 3, 2024
Solid pick for teams standardizing on skills: ra-qm-skills is focused, and the summary matches what you get after install.
- ★★★★★Pratham Ware· Feb 2, 2024
We added ra-qm-skills from the explainx registry; install was straightforward and the SKILL.md answered most questions upfront.
- ★★★★★Yash Thakker· Jan 1, 2024
ra-qm-skills fits our agent workflows well — practical, well scoped, and easy to wire into existing repos.