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secrets-vault-manager (403-line SKILL.md, 3 scripts, 3 references): - HashiCorp Vault, AWS SM, Azure KV, GCP SM integration - Secret rotation, dynamic secrets, audit logging, emergency procedures sql-database-assistant (457-line SKILL.md, 3 scripts, 3 references): - Query optimization, migration generation, schema exploration - Multi-DB support (PostgreSQL, MySQL, SQLite, SQL Server) - ORM patterns (Prisma, Drizzle, TypeORM, SQLAlchemy) gcp-cloud-architect (418-line SKILL.md, 3 scripts, 3 references): - 6-step workflow mirroring aws-solution-architect for GCP - Cloud Run, GKE, BigQuery, Cloud Functions, cost optimization - Completes cloud trifecta (AWS + Azure + GCP) soc2-compliance (417-line SKILL.md, 3 scripts, 3 references): - SOC 2 Type I & II preparation, Trust Service Criteria mapping - Control matrix generation, evidence tracking, gap analysis - First SOC 2 skill in ra-qm-team (joins GDPR, ISO 27001, ISO 13485) All 12 scripts pass --help. Docs generated, mkdocs.yml nav updated. Co-Authored-By: Claude Opus 4.6 (1M context) <noreply@anthropic.com>
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title, description
| title | description |
|---|---|
| Regulatory & Quality Skills — Agent Skills & Codex Plugins | 14 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
14 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.
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SOC 2 Type I and Type II compliance preparation for SaaS companies. Covers Trust Service Criteria mapping, control ma...