ra-qm-skills
Provides 12 production-ready Regulatory Affairs and Quality Management skills for HealthTech and MedTech organizations, ensuring compliance and quality standards.
npx skills add https://github.com/alirezarezvani/claude-skills --skill ra-qm-skillsBefore / After Comparison
1 组Manually researching regulatory requirements such as FDA, CE, and ISO, writing compliance documents, tracking regulatory changes, and managing audit processes, easily missing important updates.
Using pre-configured compliance skills to automatically generate standard-compliant documents, track regulatory changes, and manage audit processes, ensuring continuous compliance.
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
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Load only the specific skill SKILL.md you need
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Always verify compliance outputs against current regulations
Weekly Installs256Repositoryalirezarezvani/…e-skillsGitHub Stars6.7KFirst SeenMar 9, 2026Security AuditsGen Agent Trust HubPassSocketWarnSnykPassInstalled oncodex245opencode245gemini-cli244github-copilot243amp243kimi-cli243
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