---
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."
---

<div class="domain-header" markdown>

# :material-shield-check-outline: Regulatory & Quality

<p class="domain-count">18 skills in this domain</p>

</div>

<div class="install-banner" markdown>
<span class="install-label">Install all:</span> <code>claude /plugin install ra-qm-skills</code>
</div>

<div class="grid cards" markdown>

-   **[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, the Quality Management Syste...

-   **[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)**

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    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)**

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    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)**

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    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 — Router](ra-qm-skills.md)**

    ---

    This plugin bundles 15 compliance skills for HealthTech/MedTech organizations (this router is the 16th folder under r...

-   **[Head of Regulatory Affairs](regulatory-affairs-head.md)**

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    Regulatory strategy development, submission management, and global market access for medical device organizations.

-   **[Risk Management Specialist](risk-management-specialist.md)**

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    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...

</div>
