--- title: "Regulatory & Quality Skills — Agent Skills & Codex Plugins" description: "18 regulatory & quality skills — regulatory and quality management agent skill for ISO 13485, MDR, FDA, and GDPR compliance. Works with Claude Code, Codex CLI, Gemini CLI, and OpenClaw." ---
# :material-shield-check-outline: Regulatory & Quality

18 skills in this domain

Install all: claude /plugin install ra-qm-skills
- **[CAPA Officer](capa-officer.md)** --- Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cau... - **[EU AI Act Compliance Specialist](eu-ai-act-specialist.md)** --- Article-cited operational skill for Regulation (EU) 2024/1689. Three decisions, no executive AI strategy: - **[FDA Consultant Specialist](fda-consultant-specialist.md)** --- FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (Q... - **[GDPR/DSGVO Expert](gdpr-dsgvo-expert.md)** --- Tools and guidance for EU General Data Protection Regulation (GDPR) and German Bundesdatenschutzgesetz (BDSG) complia... - **[Information Security Manager - ISO 27001](information-security-manager-iso27001.md)** --- Implement and manage Information Security Management Systems (ISMS) aligned with ISO 27001:2022 and healthcare regula... - **[ISMS Audit Expert](isms-audit-expert.md)** --- Internal and external ISMS audit management for ISO 27001 compliance verification, security control assessment, and c... - **[ISO/IEC 42001 AI Management System Specialist](iso42001-specialist.md)** --- Internal-audit-grade operating skill for ISO/IEC 42001:2023. Three decisions, no executive AI strategy: - **[MDR 2017/745 Specialist](mdr-745-specialist.md)** --- EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence. - **[QMS Audit Expert](qms-audit-expert.md)** --- ISO 13485 internal audit methodology for medical device quality management systems. - **[Quality Documentation Manager](quality-documentation-manager.md)** --- Document control system design and management for ISO 13485-compliant quality management systems, including numbering... - **[Senior Quality Manager Responsible Person (QMR)](quality-manager-qmr.md)** --- Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause... - **[Quality Manager - QMS ISO 13485 Specialist](quality-manager-qms-iso13485.md)** --- ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device or... - **[Regulatory Affairs & Quality Management Skills](ra-qm-skills.md)** --- 12 production-ready compliance skills for HealthTech and MedTech organizations. - **[Head of Regulatory Affairs](regulatory-affairs-head.md)** --- Regulatory strategy development, submission management, and global market access for medical device organizations. - **[Risk Management Specialist](risk-management-specialist.md)** --- ISO 14971:2019 risk management implementation throughout the medical device lifecycle. - **[SOC 2 Compliance](soc2-compliance.md)** --- SOC 2 Type I and Type II compliance preparation for SaaS companies. Covers Trust Service Criteria mapping, control ma...