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FDA (Finally) Harmonizes Medical Device Manufacturing Requirements With ISO | Cooley LLP

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). By issuing this rule, FDA amended. ....

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FDA Issues Long-Awaited QMSR Final Rule - Life Sciences, Biotechnology & Nanotechnology

More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. ....

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New FDA QMSR Through The Lens Of Risk Management Requirements And Analysis

New FDA QMSR Through The Lens Of Risk Management Requirements And Analysis
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Quality System Harmonization Is Here, But With Small Benefit To Device Industry - Life Sciences, Biotechnology & Nanotechnology

After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820. ....

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