AI is emerging as a powerful tool to support quality and regulatory professionals navigating complex, global requirements. Regulators like the FDA and MedTech Europe highlight AI’s role in improving automation, predictive modeling, regulatory review, and postmarket surveillance. Applications include scanning global datasets to flag safety signals, suggesting testing parameters, and drafting submission templates. Benefits include faster workflows, fewer manual tasks, and richer insights. However, risks such as bias, transparency gaps, and patient safety concerns mean AI must augment, not replace, human decision-making. Proper validation, governance, and regulatory controls remain essential.

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