670930c69d
- Add CSS components: .page-meta badges, .domain-header, .install-banner - Fix invisible tab navigation (explicit color for light/dark modes) - Rewrite generate-docs.py with design system templates - Domain indexes: centered headers with icons, install banners, grid cards - Skill pages: pill badges (domain, skill ID, source), install commands - Agent/command pages: type badges with domain icons - Regenerate all 210 pages (180 skills + 15 agents + 15 commands) Co-Authored-By: Claude Opus 4.6 <noreply@anthropic.com>
99 lines
2.9 KiB
Markdown
99 lines
2.9 KiB
Markdown
---
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title: "Regulatory & Quality Skills"
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description: "All 13 Regulatory & Quality skills for Claude Code, Codex CLI, Gemini CLI, and OpenClaw."
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---
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<div class="domain-header" markdown>
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# :material-shield-check-outline: Regulatory & Quality
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<p class="domain-count">13 skills in this domain</p>
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</div>
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<div class="install-banner" markdown>
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<span class="install-label">Install all:</span> <code>claude /plugin install ra-qm-skills</code>
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</div>
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<div class="grid cards" markdown>
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- **[CAPA Officer](capa-officer.md)**
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Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cau...
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- **[FDA Consultant Specialist](fda-consultant-specialist.md)**
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---
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FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (Q...
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- **[GDPR/DSGVO Expert](gdpr-dsgvo-expert.md)**
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---
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Tools and guidance for EU General Data Protection Regulation (GDPR) and German Bundesdatenschutzgesetz (BDSG) complia...
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- **[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...
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- **[ISMS Audit Expert](isms-audit-expert.md)**
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---
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Internal and external ISMS audit management for ISO 27001 compliance verification, security control assessment, and c...
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- **[MDR 2017/745 Specialist](mdr-745-specialist.md)**
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EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence.
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- **[QMS Audit Expert](qms-audit-expert.md)**
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---
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ISO 13485 internal audit methodology for medical device quality management systems.
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- **[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...
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- **[Senior Quality Manager Responsible Person (QMR)](quality-manager-qmr.md)**
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Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause...
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- **[Quality Manager - QMS ISO 13485 Specialist](quality-manager-qms-iso13485.md)**
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---
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ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device or...
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- **[Regulatory Affairs & Quality Management Skills](ra-qm-team.md)**
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---
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12 production-ready compliance skills for HealthTech and MedTech organizations.
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- **[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.
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- **[Risk Management Specialist](risk-management-specialist.md)**
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---
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ISO 14971:2019 risk management implementation throughout the medical device lifecycle.
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</div>
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