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Tagged regulatory

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  • September 7, 2026 · 7 min read

    Change the Model, Restart the Submission

    In most software, retraining is a Tuesday. In a regulated device it can be a regulatory event, and the cost is not the retraining but the clearance cycle it can trigger. That asymmetry should change your architecture, not just your paperwork, because the decisions that determine how often you must retrain are made long before the first submission.

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