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

Weekly Installs256Repositoryalirezarezvani/…e-skillsGitHub Stars6.7KFirst SeenMar 9, 2026Security AuditsGen Agent Trust HubPassSocketWarnSnykPassInstalled oncodex245opencode245gemini-cli244github-copilot243amp243kimi-cli243