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