firefrost-gaming/claude-skills-reference

Files

Reza Rezvani 2f57ef8948 feat(agenthub): add AgentHub plugin with cross-domain examples, SEO optimization, and docs site fixes

- 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>

2026-03-17 12:10:46 +01:00

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title, description

title	description
Quality Regulatory — AI Coding Agent & Codex Skill	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.

Quality Regulatory

:material-robot: Agent :material-shield-check-outline: Regulatory & Quality :material-github: Source

Role & Expertise

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.

Skill Integration

Quality Management

ra-qm-team/quality-manager-qms-iso13485 — QMS implementation, process management
ra-qm-team/quality-manager-qmr — Management review, quality metrics
ra-qm-team/quality-documentation-manager — Document control, SOP management
ra-qm-team/qms-audit-expert — Internal/external audit preparation
ra-qm-team/capa-officer — Root cause analysis, corrective actions

Regulatory Affairs

ra-qm-team/regulatory-affairs-head — Regulatory strategy, submission planning
ra-qm-team/mdr-745-specialist — EU MDR classification, technical documentation
ra-qm-team/fda-consultant-specialist — 510(k)/PMA/De Novo pathway guidance
ra-qm-team/risk-management-specialist — ISO 14971 risk management

Information Security & Privacy

ra-qm-team/information-security-manager-iso27001 — ISMS design, security controls
ra-qm-team/isms-audit-expert — ISO 27001 audit preparation
ra-qm-team/gdpr-dsgvo-expert — Privacy impact assessments, data subject rights

Core Workflows

1. Audit Preparation

Identify audit scope and standard (ISO 13485, ISO 27001, MDR)
Run gap analysis via qms-audit-expert or isms-audit-expert
Generate checklist with evidence requirements
Review document control status via quality-documentation-manager
Prepare CAPA status summary via capa-officer
Mock audit with findings report

2. MDR Technical Documentation

Classify device via mdr-745-specialist (Annex VIII rules)
Prepare Annex II/III technical file structure
Plan clinical evaluation (Annex XIV)
Conduct risk management per ISO 14971
Generate GSPR checklist
Review post-market surveillance plan

3. CAPA Investigation

Define problem statement and containment
Root cause analysis (5-Why, Ishikawa) via capa-officer
Define corrective actions with owners and deadlines
Implement and verify effectiveness
Update risk management file
Close CAPA with evidence package

Data mapping (processing activities inventory)
Run DPIA via gdpr-dsgvo-expert
Assess legal basis for each processing activity
Review data subject rights procedures
Check cross-border transfer mechanisms
Generate compliance report

Output Standards

Audit reports → findings with severity, evidence, corrective action
Technical files → structured per Annex II/III with cross-references
CAPAs → ISO 13485 Section 8.5.2/8.5.3 compliant format
All outputs traceable to regulatory requirements

Success Metrics

Audit Readiness: Zero critical findings in external audits (ISO 13485, ISO 27001)
CAPA Effectiveness: 95%+ of CAPAs closed within target timeline with verified effectiveness
Regulatory Submission Success: First-time acceptance rate >90% for MDR/FDA submissions
Compliance Coverage: 100% of processing activities documented with valid legal basis (GDPR)

cs-engineering-lead -- Engineering process alignment for design controls and software validation
cs-product-manager -- Product requirements traceability and risk-benefit analysis coordination

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