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ra-qm-skills

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.

Publisher marketplacera-qm-skills@claude-code-skills · marketplace and plugin share one repository (adamtasteslikegood/alirez-claude-skills)

npx claudepluginhub adamtasteslikegood/alirez-claude-skills --plugin ra-qm-skills

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Med: 0·Avg: 488

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Med: 0·Avg: 1

What's Inside

Skills17

agent-decision-receipts

/agent-decision-receipts

Mint a tamper-evident, post-quantum-signed receipt for a consequential agent action (deploy, delete, pay, grant-access, model decision) so it can be verified later from the certificate alone. Use when an autonomous agent takes a side-effecting action that may need to be proven later, or when satisfying EU AI Act Article 12 record-keeping. Three decisions: whether an action needs a receipt, minting it, verifying it. Signing is delegated to the open-source OpenAgentOntology package. Not after-the-fact log analysis; not a hosted notary; not a legal opinion.

capa-officer

/capa-officer

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-specialist

/eu-ai-act-specialist

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-consultant-specialist

/fda-consultant-specialist

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-dsgvo-expert

/gdpr-dsgvo-expert

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.

The plugin manifest points to a different repository than the source indexed by ClaudePluginHub.

Stats

Version2.9.0

ReleasedJun 13, 2026

LanguagePython

Stars1

MaintenanceExcellent

LicenseMIT

Last CommitJul 1, 2026

AddedJul 18, 2026

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claude-code-skills1

README

Claude Code Skills & Plugins — Agent Skills for Every Coding Tool

351 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.

What Are Claude Code Skills & Agent Plugins?

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:

SKILL.md — structured instructions, workflows, and decision frameworks
Python tools — 590 CLI scripts (all stdlib-only, zero pip installs)
Reference docs — 711 templates, checklists, and domain-specific knowledge files

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 590 Python tools run anywhere Python runs.

Skills vs Agents vs Personas

	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.

Quick Install

Gemini CLI (New)

# 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")

Claude Code (Recommended)

# 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. ↩

View full README on GitHub

More by adamtasteslikegood

general-counsel-advisor

1·

General Counsel advisory for startups: contract risk scanner (12 founder-killer patterns: auto-renew traps, uncapped indemnity, vague IP, MFN pricing, missing DPA, one-sided venue, broad non-solicit, perpetual license-back, etc.) and term sheet analyzer (0-100 founder-friendliness score across 12 dimensions: liquidation preference, anti-dilution, option pool, board, vesting, drag-along, protective provisions, info rights, dividends, valuation). 3 in-depth references: contracts playbook (7 startup contract types), IP + regulatory landscape (HIPAA, GDPR, FDA, fintech, EU AI Act + SOC 2 to ISO sequencing), term sheet decoder. Stdlib-only. Standalone-installable; also bundled in c-level-skills. NOT a substitute for licensed counsel.

1mo

v2.9.0

adamtasteslikegood

chief-data-officer-advisor

1·

Chief Data Officer advisory: AI training data audit (origin x class x use-case matrix with GDPR Art. 6 + EU AI Act citations -> GO/MITIGATE/NO-GO per source), data product strategy picker (warehouse vs lakehouse vs mesh + 6-layer build-vs-buy + 12-month sequencing), data asset valuator (strategic value 0-10 + M&A multiplier with carve-out penalties + 3 ranked productization paths). 4 references answering one decision each: training rights, data product strategy, customer-data-as-asset, data team org evolution. Stdlib-only. Standalone-installable; also bundled in c-level-skills. Strategic only - does not duplicate engineering data skills.

1mo

v2.9.0

adamtasteslikegood

arquiteto-de-empresa

1·

Company Architect: builds a business from scratch as an OKF (Open Knowledge Format) bundle — a tree of version-controllable .md files with frontmatter type, links forming a graph, and reserved index.md/log.md, readable by humans and agents. Guides the founder through a 12-phase interview (foundation, strategy, market, financial, sales, marketing, product, operations, tech, people, legal, governance), one phase at a time, and generates conformant markdown concepts. 3 stdlib tools: scaffold_bundle (bundle scaffolding), okf_linter (validates type/reserved files/links), index_generator (regenerates the index.md files). Standalone-installable; also bundled in c-level-skills.

v2.10.3

adamtasteslikegood

vpe-advisor

1·

VP of Engineering advisory: delivery throughput analyzer (DORA 4 metrics + cycle-time bottleneck identification), eng hiring funnel calculator (7-stage conversion + pipeline gap + weakest-stage fixes), eng team structure designer (squad/tribe model + manager-trigger + director-trigger + span-of-control). 4 in-depth references: DORA framework, eng hiring funnel, eng team structure (Conway's Law), production discipline (on-call, incidents, deployment, SLOs). Stdlib-only. Standalone-installable; also bundled in c-level-skills. NOT a CTO skill — VPE owns how the team ships, CTO owns what to build.

1mo

v2.9.0

adamtasteslikegood

chief-ai-officer-advisor

1·

Chief AI Officer advisory: model build-vs-buy calculator (API vs fine-tune vs build with 3-year TCO across 6 paths + breakeven balancing economics with practical feasibility), AI risk classifier (EU AI Act tier with 7 Article citations + US state patchwork: NYC LL 144, CO AI Act, IL HB 53, CA SB 1001, IL BIPA + industry overlays for FDA AI/ML, CFPB Circular 2023-03, NYDFS Reg 23, NAIC, ECOA, Fed SR 11-7), AI cost economics (API vs self-hosted breakeven with 2026 pricing across A100/H100, utilization reality, hidden costs). 4 in-depth references each citing 5+ authoritative sources. Stdlib-only. Standalone-installable; also bundled in c-level-skills. Strategic only - does not duplicate engineering AI/ML skills.

1mo

v2.9.0

adamtasteslikegood

ra-qm-skills

Popularity

What's Inside

Confidence

README

Claude Code Skills & Plugins — Agent Skills for Every Coding Tool

What Are Claude Code Skills & Agent Plugins?

Skills vs Agents vs Personas

Quick Install

Gemini CLI (New)

Claude Code (Recommended)

Footnotes

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general-counsel-advisor

chief-data-officer-advisor

arquiteto-de-empresa

vpe-advisor

chief-ai-officer-advisor

Claude Code Skills & Plugins — Agent Skills for Every Coding Tool

What Are Claude Code Skills & Agent Plugins?

Skills vs Agents vs Personas

Quick Install

Gemini CLI (New)

Claude Code (Recommended)

Footnotes

Popularity

Health & Quality

More by adamtasteslikegood

general-counsel-advisor

chief-data-officer-advisor

arquiteto-de-empresa

vpe-advisor

chief-ai-officer-advisor

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