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
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