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 ```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 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: ```bash python3 risk-management-speci...