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>
2.9 KiB
title, description
| title | description |
|---|---|
| Regulatory & Quality Skills | All 13 Regulatory & Quality skills for Claude Code, Codex CLI, Gemini CLI, and OpenClaw. |
:material-shield-check-outline: Regulatory & Quality
13 skills in this domain
claude /plugin install ra-qm-skills
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Corrective and Preventive Action (CAPA) management within Quality Management Systems, focusing on systematic root cau...
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FDA regulatory consulting for medical device manufacturers covering submission pathways, Quality System Regulation (Q...
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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
Implement and manage Information Security Management Systems (ISMS) aligned with ISO 27001:2022 and healthcare regula...
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Internal and external ISMS audit management for ISO 27001 compliance verification, security control assessment, and c...
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EU MDR compliance patterns for medical device classification, technical documentation, and clinical evidence.
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ISO 13485 internal audit methodology for medical device quality management systems.
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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 system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause...
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Quality Manager - QMS ISO 13485 Specialist
ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device or...
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Regulatory Affairs & Quality Management Skills
12 production-ready compliance skills for HealthTech and MedTech organizations.
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Regulatory strategy development, submission management, and global market access for medical device organizations.
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ISO 14971:2019 risk management implementation throughout the medical device lifecycle.