菜单
12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only).
用 Codex 或 Claude 帮你安装 复制这段 Prompt，粘贴到 Codex、Claude 或其他助手里，让它检查 Skill 页面并帮你完成安装。
基于 SOC 职业分类
Use when writing, reviewing, or committing code to enforce Karpathy's 4 coding principles — surface assumptions before coding, keep it simple, make surgical changes, define verifiable goals. Triggers on "review my diff", "check complexity", "am I overcomplicating this", "karpathy check", "before I commit", or any code quality concern where the LLM might be overcoding.
Use proactively whenever LLM API costs come up -- or should. Triggers include: 'my AI costs are too high', 'optimize token usage', 'which model should I use', 'LLM spend is out of control', 'implement prompt caching', 'we're about to launch an AI feature', 'build me an AI endpoint'. Don't wait for an explicit cost complaint -- if someone is building an AI feature, designing an LLM endpoint, or choosing between models, cost architecture belongs in the conversation. Apply immediately when any of these are true: a system prompt appears that exceeds a few hundred tokens, all requests are hitting the same model, max_tokens is not set, or no per-feature cost logging exists. NOT for RAG pipeline design (use rag-architect). NOT for improving prompt quality or effectiveness (use senior-prompt-engineer).
25 advanced engineering agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. Agent design, RAG, MCP servers, CI/CD, database design, observability, security auditing, release management, platform ops.
23 engineering agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw, and 6 more tools. Architecture, frontend, backend, QA, DevOps, security, AI/ML, data engineering, Playwright, Stripe, AWS, MS365. 30+ Python tools (stdlib-only).
Full content production pipeline — takes a topic from blank page to published-ready piece. Use when you need to execute content: write a blog post, article, or guide end-to-end. Triggers: 'write a post about', 'draft an article', 'create content for', 'help me write', 'I need a blog post'. NOT for content strategy or calendar planning (use content-strategy). NOT for repurposing existing content (use content-repurposing). NOT for social captions only.
When the user wants to edit, review, or improve existing marketing copy. Also use when the user mentions 'edit this copy,' 'review my copy,' 'copy feedback,' 'proofread,' 'polish this,' 'make this better,' or 'copy sweep.' This skill provides a systematic approach to editing marketing copy through multiple focused passes.
| name | ra-qm-skills |
| description | 12 regulatory & QM agent skills and plugins for Claude Code, Codex, Gemini CLI, Cursor, OpenClaw. ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO, risk management (ISO 14971), CAPA, document control, auditing. Python tools (stdlib-only). |
| version | 1.0.0 |
| author | Alireza Rezvani |
| license | MIT |
| tags | ["regulatory","quality-management","iso-13485","mdr","fda","iso-27001","gdpr"] |
| agents | ["claude-code","codex-cli","openclaw"] |
12 production-ready compliance skills for HealthTech and MedTech organizations.
/read ra-qm-team/regulatory-affairs-head/SKILL.md
npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team
| Skill | Folder | Focus |
|---|---|---|
| Regulatory Affairs Head | regulatory-affairs-head/ | FDA/MDR strategy, submissions |
| Quality Manager (QMR) | quality-manager-qmr/ | QMS governance, management review |
| Quality Manager (ISO 13485) | quality-manager-qms-iso13485/ | QMS implementation, doc control |
| Risk Management Specialist | risk-management-specialist/ | ISO 14971, FMEA, risk files |
| CAPA Officer | capa-officer/ | Root cause analysis, corrective actions |
| Quality Documentation Manager | quality-documentation-manager/ | Document control, 21 CFR Part 11 |
| QMS Audit Expert | qms-audit-expert/ | ISO 13485 internal audits |
| ISMS Audit Expert | isms-audit-expert/ | ISO 27001 security audits |
| Information Security Manager | information-security-manager-iso27001/ | ISMS implementation |
| MDR 745 Specialist | mdr-745-specialist/ | EU MDR classification, CE marking |
| FDA Consultant | fda-consultant-specialist/ | 510(k), PMA, QSR compliance |
| GDPR/DSGVO Expert | gdpr-dsgvo-expert/ | Privacy compliance, DPIA |
17 scripts, all stdlib-only:
python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help
python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help