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Federal Food Drug and Cosmetic Act (FFDCA) › International Organization for Standardization › Medical Devices

Mintz - Health Care Viewpoints

Quality System Harmonization Is Here, But with Small Benefit to Device Industry

Mintz - Health Care Viewpoints on

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 internationally accepted standard for...more

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