From Safety Documentation to Safety Knowledge Support: An Evidence-Grounded LLM Framework for Medical Devices
Medical devices are becoming more software-intensive, connected, and AI-enabled. Their development requires risk-management evidence aligned with ISO 14971 and, for software, IEC 62304. This evidence must be kept consistent across requirements, design decisions, software changes, verification results, complaints, and post-market data. These tasks are costly and depend on scarce safety and domain experts. Large language models (LLMs) may reduce parts of this effort because medical-device safety w
Record details
Published: 12 August 2026
Source: arXiv
Category: Research
Topics: Healthcare
Retrieved: 13 August 2026
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How to cite this record
ethics.ai (12 August 2026), “From Safety Documentation to Safety Knowledge Support: An Evidence-Grounded LLM Framework for Medical Devices,” evidence record 18780, https://ethics.ai/record/18780 (originally published by arXiv).
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