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- Japan’s PMDA releases guidance on evaluating generative AI-enabled medical devicesJapan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a set of review points aimed at medical devices that incorporate generative artificial intelligence. The guidance outlines th…
- MedTech firms grow more comfortable with FDA's Quality Management System Regulation amid inspection concernsAt The MedTech Conference in Boston, a senior industry executive reported that the medtech sector is gradually accepting the new Quality Management System Regulation (QMSR) despite early worries.…