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ra-qm-skills

v2.2.0compliance9,694 stars

13 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, SOC 2 compliance.

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/plugin install ra-qm-skills@alirezarezvani-claude-skills
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regulatory · quality · compliance · iso-13485 · mdr · fda · gdpr · medtech