arXiv subjects

Peter Liggesmeyer

Publications and source records attributed to Peter Liggesmeyer.

6 recordsLinked to original sources

arXiv2026

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.

cs.SE↗

arXiv2024

Dynamic Risk Management in Cyber Physical Systems

Cyber Physical Systems (CPS) enable new kinds of applications as well as significant improvements of existing ones in numerous different application domains. A major trait of upcoming CPS is an increasing degree of automation up to the point of autonomy, as there is a huge potential for economic success as well as for ecologic and societal improvements. However, to unlock the full potential of such (cooperative and automated) CPS, we first need to overcome several significant engineering challenges, where safety assurance is a particularly important one. Unfortunately, established safety assurance methods and standards do not live up to this task, as they have been designed with closed and less complex systems in mind. This paper structures safety assurance challenges of cooperative automated CPS, provides an overview on our vision of dynamic risk management and describes already existing building blocks.

cs.SE↗

arXiv2024

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.

eess.SY↗

arXiv2023

Systematic Modeling Approach for Environmental Perception Limitations in Automated Driving

Highly automated driving (HAD) vehicles are complex systems operating in an open context. Complexity of these systems as well as limitations and insufficiencies in sensing and understanding the open context may result in unsafe and uncertain behavior. The safety critical nature of the HAD vehicles demands to model limitations, insufficiencies and triggering conditions to argue safe behavior. Standardization activities such as ISO/PAS 21448 provide guidelines on the safety of the intended functionality (SOTIF) and focus on the performance limitations and triggering conditions. Although, SOTIF provides a non-exhaustive list of scenario factors that may serve as a starting point to identify and analyze performance limitations and triggering conditions, yet no concrete methodology is provided to model these factors. We propose a novel methodology to model triggering conditions and performance limitations in a scene to assess SOTIF. We utilize Bayesian network (BN) in this regard. The experts provide the BN structure and conditional belief tables are learned using the maximum likelihood estimator. We provide performance limitation maps (PLMs) and conditional performance limitation maps (CPLMs), given a scene. As a case study, we provide PLMs and CPLMs of LIDAR in a defined scene using real world data.

eess.SY↗

arXiv2023

Discovery of Perception Performance Limiting Triggering Conditions in Automated Driving

Highly automated driving (HAD) vehicles are complex systems operating in an open context. Performance limitations originating from sensing and understanding the open context under triggering conditions may result in unsafe behavior, thus, need to be identified and modeled. This aspect of safety is also discussed in standardization activities such as ISO 21448, safety of the intended functionality (SOTIF). Although SOTIF provides a non-exhaustive list of scenario factors to identify and analyze performance limitations under triggering conditions, no concrete methodology is yet provided to identify novel triggering conditions. We propose a methodology to identify and model novel triggering conditions in a scene in order to assess SOTIF using Bayesian network (BN) and p-value hypothesis testing. The experts provide the initial BN structure while the conditional belief tables (CBTs) are learned using dataset. P-value hypothesis testing is used to identify the relevant subset of scenes. These scenes are then analyzed by experts who provide potential triggering conditions present in the scenes. The novel triggering conditions are modeled in the BN and retested. As a case study, we provide p-value hypothesis testing of BN of LIDAR using real world data.

eess.SY↗

arXiv2014

Visualization of Software and Systems as Support Mechanism for Integrated Software Project Control

Many software development organizations still lack support for obtaining intellectual control over their software development processes and for determining the performance of their processes and the quality of the produced products. Systematic support for detecting and reacting to critical process and product states in order to achieve planned goals is usually missing. One means to institutionalize measurement on the basis of explicit models is the development and establishment of a so-called Software Project Control Center (SPCC) for systematic quality assurance and management support. An SPCC is comparable to a control room, which is a well known term in the mechanical production domain. One crucial task of an SPCC is the systematic visualization of measurement data in order to provide context-, purpose-, and role-oriented information for all stakeholders (e.g., project managers, quality assurance managers, developers) during the execution of a software development project. The article will present an overview of SPCC concepts, a concrete instantiation that supports goal-oriented data visualization, as well as examples and experiences from practical applications.

cs.SE↗