ra-qm-skills

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