Currently browsing "FDA"
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What the FDA’s New QMSR Means for Your Quality System — and Whether You’re Actually Ready
On February 2, 2026, the FDA replaced a regulation that had governed medical device quality systems for nearly three decades. The Quality System Regulation (QSR), which had structured how device manufacturers operated under 21 CFR Part 820 since 1996, gave way to the Quality Management System Regulation — the QMSR. The old framework is gone. […]
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Understanding FDA Software Validation
In the dynamic landscape of healthcare technology, the development and deployment of software play a crucial role in patient care, diagnostics, and overall healthcare management. However, with innovation comes the need for stringent regulations to ensure the safety and effectiveness of medical software. The Food and Drug Administration (FDA) plays a pivotal role in overseeing […]
