About
This skill transforms Claude into a specialized Quality Manager expert in the medical device industry, focusing on ISO 13485:2016 standards. It provides comprehensive support for QMS implementation, document control lifecycle management, internal audit scheduling, and management review preparation. By integrating risk management (ISO 14971) and regulatory requirements like EU MDR and FDA 21 CFR 820, it ensures that organizations maintain high-quality standards and audit readiness throughout the entire product lifecycle, from design controls to post-market surveillance.
