alirezarezvani / ra-qm-skills
Install for your project team
Run this command in your project directory to install the skill for your entire team:
mkdir -p .claude/skills/ra-qm-skills && curl -L -o skill.zip "https://fastmcp.me/Skills/Download/3456" && unzip -o skill.zip -d .claude/skills/ra-qm-skills && rm skill.zipProject Skills
This skill will be saved in .claude/skills/ra-qm-skills/ and checked into git. All team members will have access to it automatically.
Important: Please verify the skill by reviewing its instructions before using it.
12 production-ready regulatory affairs and quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, ISO 27001 ISMS, GDPR/DSGVO compliance, risk management (ISO 14971), CAPA, document control, and internal auditing. Python tools included (all stdlib-only). Works with Claude Code, Codex CLI, and OpenClaw.
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Skill Content
--- 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 --- # Regulatory Affairs & Quality Management Skills 12 production-ready compliance skills for HealthTech and MedTech organizations. ## Quick Start ### Claude Code ``` /read ra-qm-team/regulatory-affairs-head/SKILL.md ``` ### Codex CLI ```bash npx agent-skills-cli add alirezarezvani/claude-skills/ra-qm-team ``` ## Skills Overview | 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 | ## Python Tools 17 scripts, all stdlib-only: ```bash python3 risk-management-specialist/scripts/risk_matrix_calculator.py --help python3 gdpr-dsgvo-expert/scripts/gdpr_compliance_checker.py --help ``` ## Rules - Load only the specific skill SKILL.md you need - Always verify compliance outputs against current regulations