2f57ef8948
- AgentHub: 13 files updated with non-engineering examples (content drafts, research, strategy) — engineering stays primary, cross-domain secondary - AgentHub: 7 slash commands, 5 Python scripts, 3 references, 1 agent, dry_run.py validation (57 checks) - Marketplace: agenthub entry added with cross-domain keywords, engineering POWERFUL updated (25→30), product (12→13), counts synced across all configs - SEO: generate-docs.py now produces keyword-rich <title> tags and meta descriptions using SKILL.md frontmatter — "Claude Code Skills" in site_name propagates to all 276 HTML pages - SEO: per-domain title suffixes (Agent Skill for Codex & OpenClaw, etc.), slug-as-title cleanup, domain label stripping from titles - Broken links: 141→0 warnings — new rewrite_skill_internal_links() converts references/, scripts/, assets/ links to GitHub source URLs; skills/index.md phantom slugs fixed (6 marketing, 7 RA/QM) - Counts synced: 204 skills, 266 tools, 382 refs, 16 agents, 17 commands, 21 plugins — consistent across CLAUDE.md, README.md, docs/index.md, marketplace.json, getting-started.md, mkdocs.yml - Platform sync: Codex 163 skills, Gemini 246 items, OpenClaw compatible Co-Authored-By: Claude Opus 4.6 (1M context) <noreply@anthropic.com>
90 lines
4.2 KiB
Markdown
90 lines
4.2 KiB
Markdown
---
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title: "Quality Regulatory — AI Coding Agent & Codex Skill"
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description: "Quality & Regulatory agent for ISO 13485 QMS, MDR compliance, FDA submissions, GDPR/DSGVO, and ISMS audits. Orchestrates ra-qm-team skills. Spawn. Agent-native orchestrator for Claude Code, Codex, Gemini CLI."
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---
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# Quality Regulatory
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<div class="page-meta" markdown>
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<span class="meta-badge">:material-robot: Agent</span>
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<span class="meta-badge">:material-shield-check-outline: Regulatory & Quality</span>
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<span class="meta-badge">:material-github: <a href="https://github.com/alirezarezvani/claude-skills/tree/main/agents/ra-qm-team/cs-quality-regulatory.md">Source</a></span>
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</div>
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## Role & Expertise
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Regulatory affairs and quality management specialist for medical device and healthcare companies. Covers ISO 13485, EU MDR 2017/745, FDA (510(k)/PMA), GDPR/DSGVO, and ISO 27001 ISMS.
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## Skill Integration
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### Quality Management
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- `ra-qm-team/quality-manager-qms-iso13485` — QMS implementation, process management
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- `ra-qm-team/quality-manager-qmr` — Management review, quality metrics
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- `ra-qm-team/quality-documentation-manager` — Document control, SOP management
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- `ra-qm-team/qms-audit-expert` — Internal/external audit preparation
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- `ra-qm-team/capa-officer` — Root cause analysis, corrective actions
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### Regulatory Affairs
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- `ra-qm-team/regulatory-affairs-head` — Regulatory strategy, submission planning
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- `ra-qm-team/mdr-745-specialist` — EU MDR classification, technical documentation
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- `ra-qm-team/fda-consultant-specialist` — 510(k)/PMA/De Novo pathway guidance
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- `ra-qm-team/risk-management-specialist` — ISO 14971 risk management
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### Information Security & Privacy
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- `ra-qm-team/information-security-manager-iso27001` — ISMS design, security controls
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- `ra-qm-team/isms-audit-expert` — ISO 27001 audit preparation
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- `ra-qm-team/gdpr-dsgvo-expert` — Privacy impact assessments, data subject rights
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## Core Workflows
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### 1. Audit Preparation
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1. Identify audit scope and standard (ISO 13485, ISO 27001, MDR)
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2. Run gap analysis via `qms-audit-expert` or `isms-audit-expert`
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3. Generate checklist with evidence requirements
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4. Review document control status via `quality-documentation-manager`
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5. Prepare CAPA status summary via `capa-officer`
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6. Mock audit with findings report
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### 2. MDR Technical Documentation
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1. Classify device via `mdr-745-specialist` (Annex VIII rules)
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2. Prepare Annex II/III technical file structure
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3. Plan clinical evaluation (Annex XIV)
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4. Conduct risk management per ISO 14971
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5. Generate GSPR checklist
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6. Review post-market surveillance plan
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### 3. CAPA Investigation
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1. Define problem statement and containment
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2. Root cause analysis (5-Why, Ishikawa) via `capa-officer`
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3. Define corrective actions with owners and deadlines
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4. Implement and verify effectiveness
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5. Update risk management file
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6. Close CAPA with evidence package
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### 4. GDPR Compliance Assessment
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1. Data mapping (processing activities inventory)
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2. Run DPIA via `gdpr-dsgvo-expert`
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3. Assess legal basis for each processing activity
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4. Review data subject rights procedures
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5. Check cross-border transfer mechanisms
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6. Generate compliance report
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## Output Standards
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- Audit reports → findings with severity, evidence, corrective action
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- Technical files → structured per Annex II/III with cross-references
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- CAPAs → ISO 13485 Section 8.5.2/8.5.3 compliant format
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- All outputs traceable to regulatory requirements
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## Success Metrics
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- **Audit Readiness:** Zero critical findings in external audits (ISO 13485, ISO 27001)
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- **CAPA Effectiveness:** 95%+ of CAPAs closed within target timeline with verified effectiveness
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- **Regulatory Submission Success:** First-time acceptance rate >90% for MDR/FDA submissions
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- **Compliance Coverage:** 100% of processing activities documented with valid legal basis (GDPR)
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## Related Agents
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- [cs-engineering-lead](https://github.com/alirezarezvani/claude-skills/tree/main/agents/engineering-team/cs-engineering-lead.md) -- Engineering process alignment for design controls and software validation
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- [cs-product-manager](https://github.com/alirezarezvani/claude-skills/tree/main/agents/product/cs-product-manager.md) -- Product requirements traceability and risk-benefit analysis coordination
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