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From 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).
How this skill is triggered — by the user, by Claude, or both
Slash command
/ra-qm-skills:ra-qm-skillsThe summary Claude sees in its skill listing — used to decide when to auto-load this skill
12 production-ready compliance skills for HealthTech and MedTech organizations.
CLAUDE.mdREADME.mdcapa-officer.zipcapa-officer/references/effectiveness-verification-guide.mdcapa-officer/references/rca-methodologies.mdcapa-officer/scripts/capa_tracker.pycapa-officer/scripts/root_cause_analyzer.pyfda-consultant-specialist.zipfda-consultant-specialist/references/device_cybersecurity_guidance.mdfda-consultant-specialist/references/fda_capa_requirements.mdfda-consultant-specialist/references/fda_submission_guide.mdfda-consultant-specialist/references/hipaa_compliance_framework.mdfda-consultant-specialist/references/qsr_compliance_requirements.mdfda-consultant-specialist/scripts/fda_submission_tracker.pyfda-consultant-specialist/scripts/hipaa_risk_assessment.pyfda-consultant-specialist/scripts/qsr_compliance_checker.pyfinal-complete-skills-collection.mdgdpr-dsgvo-expert.zipgdpr-dsgvo-expert/references/dpia_methodology.mdgdpr-dsgvo-expert/references/gdpr_compliance_guide.md12 production-ready compliance skills for HealthTech and MedTech organizations.
/read ra-qm-team/regulatory-affairs-head/SKILL.md
npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team
| 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 |
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
Guides completion of development work by verifying tests, detecting environment, and presenting structured options for merge, PR, or cleanup.
Enforces test-driven development: write failing test first, then minimal code to pass. Use when implementing features or bugfixes.
Guides creation and editing of skills using test-driven development with pressure scenarios and subagents to verify agent compliance.
29plugins reuse this skill
First indexed Jul 8, 2026
Showing the 6 earliest of 29 plugins
npx claudepluginhub cybagard/claude-skills --plugin ra-qm-skills