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FDA's new Quality Management System Regulation is here: Key takeaways for device companies in US, EU, and China

On January 21, 2024, the FDA issued a final rule amending its Quality System (QS) regulations under 21 CFR Part 820, which addresses current good… ....

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FDA to Harmonize Quality System Regulations for Medical Devices

FDA to Harmonize Quality System Regulations for Medical Devices
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Quality System Harmonization Is Here, But with Small Benefit to Device Industry | Mintz - Health Care Viewpoints

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 with the. ....

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FDA Aligns U.S. Medical Device Quality System Regulation with International Standards | King & Spalding

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System. ....

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In Search of Harmonization: FDA Finalizes Device CGMP Regulation Harmonization with ISO 13485:2016 | Foley Hoag LLP

On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this. ....

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