LLM Framework for Medical Device Safety Documentation

A recent study published on arXiv (2608.12025) introduces a framework designed to utilize large language models (LLMs) to improve safety documentation for medical devices, with an emphasis on evidence-based knowledge support. It highlights the importance of documentation that is linked to sources, traceable, and updated throughout the product lifecycle, adhering to ISO 14971 and IEC 62304 standards. The framework seeks to reduce the challenges associated with maintaining consistency in various documentation areas. Existing LLM methods are inadequate, lacking features for source linking, traceability, and lifecycle updates. This proposed framework aims to mitigate these challenges, potentially lightening the load for safety and domain specialists in the development of regulated medical devices, particularly as AI-enabled and software-intensive devices grow in prevalence.