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 p...
Tuhinangshu Gangopadhyay, Rasmus Adler, Peter Liggesmeyer et al.· 0 citations
Deploying Machine Learning (ML) models in safety-critical domains requires connecting their behavior to safety engineering standards such as IEC 61508. These standards focus on mitigating systematic failures in software, yet ML models also exhibit failures that are better treated as random and thus fall outside this sc...
Mateus Molina, Alexander Günther, Peter Liggesmeyer· International Conference on...· 0 citations
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