Ra Qm Skills
Meet HealthTech/MedTech regulatory and quality requirements: ISO 13485, MDR, FDA 510(k)/PMA, GDPR, ISO 27001, CAPA, risk management.
Install
npx skills add https://github.com/zhangzhang-111-i/claude-skills111 --skill ra-qm-teamWhat is this skill?
- ISO 13485 QMS + MDR 2017/745
- FDA 510(k)/PMA
- GDPR/DSGVO + ISO 27001 ISMS
- CAPA + clinical evaluation
Adoption & trust: 2 GitHub stars.
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Journey fit
Regulatory affairs and quality-management compliance (ISO, FDA, GDPR) are pre-release gates ensuring a product is safe and lawful to ship — the ship/security stage. ISO 27001 ISMS, GDPR, and risk/CAPA management are compliance-and-security gates, mapping to the security subphase of ship.