Ensuring compliance with relevant standards and regulations, such as IEC 62304, SaMD, ISO 14971, MDR / FDA requirements, and emerging AI-related guidance and standards (e.g. AI/ML lifecycle management, data management). * Establishing and maintaining technical and documentation overview across system interfaces, software components, data pipelines, and model lifecycle aspects. * Understanding of AI-specific challenges such as data dependency, model performance, validation, change management, and lifecycle maintenance in regulated products.
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