Regulatory Affairs & Quality Management Skills

12 production-ready compliance skills for HealthTech and MedTech organizations.

Quick Start

/read ra-qm-team/regulatory-affairs-head/SKILL.md

npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team

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

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