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Research · HFES International Symposium 2026
RAG-Enhanced LLM System with Decision Tree for Medical Device Usability Engineering Process
An AI-assisted system that pairs a 37-point decision tree with RAG-enhanced document generation (Gemini Flash and Claude Opus) to guide small and medium medical device manufacturers through the IEC 62366-1/-2 usability engineering process. Applied to four South Korean medical device companies, the framework generates usability engineering documentation while keeping human oversight at every step…