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The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed rule “Medical Devices: Quality System Regulation Amendments,” which will harmonize the current Quality...
The FDA is proposing to amend the current good manufacturing practice (cGMP) requirements of 21 CFR Part 820: Quality System Regulation (QSR) to...
After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO...
The FDA is proposing to amend the current good manufacturing practice (cGMP) requirements of 21 CFR Part 820: Quality System Regulation (QSR) to...
Investegate announcements from Sequana Medical NV, Sequana Medical receives certification under MDR, the new European Medical Device Regulation