{ "name": "ra-qm-skills", "description": "12 regulatory affairs & quality management skills for HealthTech/MedTech: ISO 13485 QMS, MDR 2017/745, FDA 510(k)/PMA, GDPR/DSGVO, ISO 27001 ISMS, CAPA management, risk management, clinical evaluation, and more", "version": "2.1.2", "author": { "name": "Alireza Rezvani", "url": "https://alirezarezvani.com" }, "homepage": "https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team", "repository": "https://github.com/alirezarezvani/claude-skills", "license": "MIT", "skills": "./" }