ra-qm-skills

SKILL.md

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