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Generative AI in MedTech: A Step-by-Step Implementation Guide

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Generative AI in MedTech becomes useful only when it is embedded in a controlled process with an identifiable owner, qualified source data, defined acceptance criteria, and review evidence. A manufacturer should therefore resist beginning with a broad enterprise assistant. The more reliable path is to select one constrained workflow, establish its regulatory context, build traceability into the architecture, and demonstrate that the system improves throughput without weakening the QMS. This tutorial follows that path from initial problem selection to a monitored production release. A practical introduction to Generative AI in MedTech should connect model capabilities to the work performed by design assurance, regulatory affairs, clinical affairs, quality, manufacturing engineering, and post-market surveillance. Those functions do not merely need fluent text. They need outputs grounded in approved records, linked to source evidence, protected from unauthorized disclosure, and routed th...