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 when running 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, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, 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 with Art. 12(3) one-month deadlines. Use when running GDPR compliance assessments, privacy audits, data protection planning, DPIA generation, or data subject rights (DSAR) management (e.g., 'check this service for GDPR risks', 'track an access request deadline'). Final compliance determinations route to the DPO or legal counsel.
ISO 27001 ISMS implementation and cybersecurity governance for HealthTech and MedTech companies. Use when designing an ISMS, running security risk assessments, implementing controls, pursuing ISO 27001 certification, preparing security audits, responding to security incidents, or verifying compliance. Covers ISO 27001, ISO 27002, healthcare security, and medical device cybersecurity.
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345 production-ready Claude Code skills, plugins, and agent skills for 13 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 9 more coding agents. Reusable expertise packages covering engineering, DevOps, marketing (incl. AEO — Answer Engine Optimization for LLM citation), security (PreToolUse hooks), compliance, C-level advisory (incl. founder-mode CFO/CMO/CRO/CPO/COO/CHRO/CISO/GC/CDO/CAIO/CCO/VPE personas + 21 /cs:* slash commands), productivity (capture/email/reflect), an academic research stack (litreview/grants/dossier/patent/syllabus/pulse/notebooklm + hybrid router), and enterprise Research Operations (clinical-research/research-finance/market-research/product-research, v2.9.0).
Works with: Claude Code · OpenAI Codex · Gemini CLI · OpenClaw · Hermes Agent1 · Mistral Vibe2 · 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, thirteen platforms. Works natively as Claude Code plugins, Codex agent skills, Gemini CLI skills, Hermes Agent skills, Mistral Vibe skills, and converts to more tools via scripts/convert.sh. All 579 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)
Hermes Agent is BYO-sync tier: the repo ships a pre-generated .hermes/skills/claude-skills/ tree, but you run python scripts/sync-hermes-skills.py once locally to install into ~/.hermes/skills/. Uses the same agentskills.io SKILL.md standard — no format conversion. ↩
Mistral Vibe is also BYO-sync tier: the repo ships a pre-generated .vibe/skills/claude-skills/ tree, run ./scripts/vibe-install.sh once locally to install into ~/.vibe/skills/. Same agentskills.io SKILL.md standard — no format conversion. Docs: https://docs.mistral.ai/mistral-vibe/agents-skills. ↩
npx claudepluginhub ai-integr8tor/alirezarezvani-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.
Tools to maintain and improve CLAUDE.md files - audit quality, capture session learnings, and keep project memory current.
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.
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.
Complete creative writing suite with 10 specialized agents covering the full writing process: research gathering, character development, story architecture, world-building, dialogue coaching, editing/review, outlining, content strategy, believability auditing, and prose style/voice analysis. Includes genre-specific guides, templates, and quality checklists.
Skills for designing and building MCP servers that work seamlessly with Claude — guides you through deployment models (remote HTTP, MCPB, local), tool design patterns, auth, and interactive MCP apps.
Lua language server for code intelligence
Active coding discipline enforcer based on Karpathy's 4 principles: surface assumptions, keep it simple, make surgical changes, define verifiable goals. Ships 4 Python tools (complexity_checker, diff_surgeon, assumption_linter, goal_verifier), a review agent, /karpathy-check slash command, and a pre-commit hook. All tools stdlib-only.
Ruby language server for code intelligence and analysis
The Terraform MCP Server provides seamless integration with Terraform ecosystem, enabling advanced automation and interaction capabilities for Infrastructure as Code (IaC) development.