Review
Aug 2026
From Safety Documentation to Safety Knowledge Support: An Evidence-Grounded LLM Framework for Medical Devices
It is argued that the central research problem is not safety-text generation, but source-linked safety-knowledge support, and an evidence-grounded framework is proposed that connects device artifacts, controlled knowledge storage and retrieval, method-specific generation of candidate safety items, critique and uncertai...
Tuhinangshu Gangopadhyay, Rasmus Adler, Peter Liggesmeyer et al.
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