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 work is highly document-based. However, current LLM-based safety-engineering studies often address isolated methods, rely on generic prompting or public examples, and provide limited support for source links, traceability, uncertainty handling, lifecycle updates, and recorded expert review. This limits their use in regulated medical-device development. This paper argues that the central research problem is not safety-text generation, but source-linked safety-knowledge support. We propose an evidence-grounded framework that connects device artifacts, controlled knowledge storage and retrieval, method-specific generation of candidate safety items, critique and uncertainty checks, and recorded expert review. The framework prepares, links, checks, and updates candidate safety artifacts for expert decision-making. It does not decide whether a device is safe and does not provide regulatory approval. We also outline an evaluation strategy using non-public or newly built medical-device case studies and expert reference analyses to assess coverage, correctness, relevance, traceability, duplicate rate, unsupported claims, and review effort.

LADRI: LeArning-based Dynamic Risk Indicator in Automated Driving System

As the horizon of intelligent transportation expands with the evolution of Automated Driving Systems (ADS), ensuring paramount safety becomes more imperative than ever. Traditional risk assessment methodologies, primarily crafted for human-driven vehicles, grapple to adequately adapt to the multifaceted, evolving environments of ADS. This paper introduces a framework for real-time Dynamic Risk Assessment (DRA) in ADS, harnessing the potency of Artificial Neural Networks (ANNs). Our proposed solution transcends these limitations, drawing upon ANNs, a cornerstone of deep learning, to meticulously analyze and categorize risk dimensions using real-time On-board Sensor (OBS) data. This learning-centric approach not only elevates the ADS's situational awareness but also enriches its understanding of immediate operational contexts. By dissecting OBS data, the system is empowered to pinpoint its current risk profile, thereby enhancing safety prospects for onboard passengers and the broader traffic ecosystem. Through this framework, we chart a direction in risk assessment, bridging the conventional voids and enhancing the proficiency of ADS. By utilizing ANNs, our methodology offers a perspective, allowing ADS to adeptly navigate and react to potential risk factors, ensuring safer and more informed autonomous journeys.