Regulatory Affairs & Quality Management Skills 12 production-ready compliance skills for HealthTech and MedTech organizations. Quick Start Claude Code Codex CLI Skills Overview | Skill | Folder | Focus | |-------|--------|-------| | Regulatory Affairs Head | | FDA/MDR strategy, submissions | | Quality Manager (QMR) | | QMS governance, management review | | Quality Manager (ISO 13485) | | QMS implementation, doc control | | Risk Management Specialist | | ISO 14971, FMEA, risk files | | CAPA Officer | | Root cause analysis, corrective actions | | Quality Documentation Manager | | Document contr…