14 regulatory affairs & quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, GDPR/DSGVO, ISO 27001 ISMS, SOC 2, CAPA management, risk management, clinical evaluation, and more. Agent skill and plugin for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw.
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
EU AI Act (Regulation (EU) 2024/1689) operational compliance for compliance teams. Three Article-level decisions: (1) What's the risk tier of this AI system — prohibited (Art. 5), high-risk (Art. 6 + Annex III), limited-risk (Art. 50), or minimal-risk? (2) For high-risk systems, what's the Article 43 conformity assessment route (Module A internal control vs Module H full QMS + notified body) and what goes in the Annex IV technical documentation? (3) Per organizational role (provider / deployer / importer / distributor / authorized representative), what are the active obligations and deadlines? Use during AI system intake review, when planning conformity assessment, or when scoping deployer obligations. Cites Articles + Annexes for every output. NOT executive AI strategy (see chief-ai-officer-advisor). NOT a legal substitute.
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
GDPR and German DSGVO compliance automation. Scans codebases for privacy risks, generates DPIA documentation, tracks data subject rights requests. Use for GDPR compliance assessments, privacy audits, data protection planning, DPIA generation, and data subject rights management.
ISO 27001 ISMS implementation and cybersecurity governance for HealthTech and MedTech companies. Use for ISMS design, security risk assessment, control implementation, ISO 27001 certification, security audits, incident response, and compliance verification. Covers ISO 27001, ISO 27002, healthcare security, and medical device cybersecurity.
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268 production-ready Claude Code skills, plugins, and agent skills for 12 AI coding tools.
The most comprehensive open-source library of Claude Code skills and agent plugins — also works with OpenAI Codex, Gemini CLI, Cursor, and 7 more coding agents. Reusable expertise packages covering engineering, DevOps, marketing, compliance, C-level advisory (incl. founder-mode CFO/CMO/CRO/CPO/COO/CHRO/CISO/GC/CDO/CAIO/CCO/VPE personas + 21 /cs:* slash commands), and more.
Works with: Claude Code · OpenAI Codex · Gemini CLI · OpenClaw · Hermes Agent · Cursor · Aider · Windsurf · Kilo Code · OpenCode · Augment · Antigravity
5,200+ GitHub stars — the most comprehensive open-source Claude Code skills & agent plugins library.
Claude Code skills (also called agent skills or coding agent plugins) are modular instruction packages that give AI coding agents domain expertise they don't have out of the box. Each skill includes:
One repo, eleven platforms. Works natively as Claude Code plugins, Codex agent skills, Gemini CLI skills, and converts to 8 more tools via scripts/convert.sh. All 373 Python tools run anywhere Python runs.
| Skills | Agents | Personas | |
|---|---|---|---|
| Purpose | How to execute a task | What task to do | Who is thinking |
| Scope | Single domain | Single domain | Cross-domain |
| Voice | Neutral | Professional | Personality-driven |
| Example | "Follow these steps for SEO" | "Run a security audit" | "Think like a startup CTO" |
All three work together. See Orchestration for how to combine them.
# Clone the repository
git clone https://github.com/alirezarezvani/claude-skills.git
cd claude-skills
# Run the setup script
./scripts/gemini-install.sh
# Start using skills
> activate_skill(name="senior-architect")
# Add the marketplace
/plugin marketplace add alirezarezvani/claude-skills
# Install by domain
/plugin install engineering-skills@claude-code-skills # 24 core engineering
/plugin install engineering-advanced-skills@claude-code-skills # 25 POWERFUL-tier
/plugin install product-skills@claude-code-skills # 12 product skills
/plugin install marketing-skills@claude-code-skills # 43 marketing skills
/plugin install ra-qm-skills@claude-code-skills # 12 regulatory/quality
/plugin install pm-skills@claude-code-skills # 6 project management
/plugin install c-level-skills@claude-code-skills # 28 C-level advisory (full C-suite)
/plugin install business-growth-skills@claude-code-skills # 4 business & growth
/plugin install finance-skills@claude-code-skills # 2 finance (analyst + SaaS metrics)
# Or install individual skills
/plugin install skill-security-auditor@claude-code-skills # Security scanner
/plugin install playwright-pro@claude-code-skills # Playwright testing toolkit
/plugin install self-improving-agent@claude-code-skills # Auto-memory curation
/plugin install content-creator@claude-code-skills # Single skill
npx agent-skills-cli add alirezarezvani/claude-skills --agent codex
# Or: git clone + ./scripts/codex-install.sh
bash <(curl -s https://raw.githubusercontent.com/alirezarezvani/claude-skills/main/scripts/openclaw-install.sh)
git clone https://github.com/alirezarezvani/claude-skills.git
# Copy any skill folder to ~/.claude/skills/ (Claude Code) or ~/.codex/skills/ (Codex)
Convert all 156 skills to 7 AI coding tools with a single script:
WCAG 2.2 accessibility audit and fix skill for React, Next.js, Vue, Angular, Svelte, and HTML. Static scanner detecting 20+ violation types, contrast checker with suggest mode, framework-specific fix patterns, CI-friendly exit codes.
Google Workspace administration via the gws CLI. Install, authenticate, and automate Gmail, Drive, Sheets, Calendar, Docs, Chat, and Tasks. 5 Python tools, 3 reference guides, 43 built-in recipes, 10 persona bundles.
Docker and container development agent skill and plugin for Dockerfile optimization, docker-compose orchestration, multi-stage builds, and container security hardening. Covers build performance, layer caching, and production-ready container patterns.
40 advanced engineering skills: agent designer, agent workflow designer, AgentHub, RAG architect, database designer, migration architect, observability designer, dependency auditor, release manager, API reviewer, CI/CD pipeline builder, MCP server builder, skill security auditor, performance profiler, Helm chart builder, Terraform patterns, focused-fix, browser-automation, spec-driven-workflow, secrets-vault-manager, sql-database-assistant, self-eval, llm-cost-optimizer, prompt-governance, llm-wiki (second brain for Obsidian + Claude Code, Karpathy pattern), tc-tracker (task context tracker with lifecycle and handoff format), feature-flags-architect, kubernetes-operator, chaos-engineering, ship-gate (pre-production 8-category audit with deploy-intent intercept), slo-architect (SLO designer, error-budget calculator with multi-window burn-rate alerts, SLO reviewer per Google SRE Workbook), and more. Agent skill and plugin for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw.
Design fluency for frontend development. 1 skill with 23 commands (/impeccable polish, /impeccable audit, /impeccable critique, etc.) and curated anti-pattern detection.
npx claudepluginhub bensitaud-hash/claude-skills --plugin ra-qm-skillsLazy senior dev mode. Forces the simplest, shortest solution that actually works: YAGNI, stdlib first, no unrequested abstractions.
Comprehensive skill pack with 66 specialized skills for full-stack developers: 12 language experts (Python, TypeScript, Go, Rust, C++, Swift, Kotlin, C#, PHP, Java, SQL, JavaScript), 10 backend frameworks, 6 frontend/mobile, plus infrastructure, DevOps, security, and testing. Features progressive disclosure architecture for 50% faster loading.
Develop, test, build, and deploy Godot 4.x games with Claude Code. Includes GdUnit4 testing, web/desktop exports, CI/CD pipelines, and deployment to Vercel/GitHub Pages/itch.io.
Tools to maintain and improve CLAUDE.md files - audit quality, capture session learnings, and keep project memory current.
A growing collection of Claude-compatible academic workflow bundles. Covers scientific figures, manuscript writing and polishing, reviewer assessment, citation retrieval, data availability, paper reading, literature search, response letters, paper-to-PPTX conversion, and evidence-grounded Chinese invention patent drafting. Rules are organized as reusable skill folders with explicit workflows and quality checks.
Evidence-gated AI coding workflow: scan → analyze → plan → TDD → execute → fix → verify → review, powered by Codebase Memory MCP >= 0.9.0 with optional Serena LSP intelligence. Includes blast-radius planning, test/cycle gates, independent review, and Windows Git Bash hook auto-resolution.