Category Archives: Design Controls

The medical device industry is a highly regulated space, with manufacturers having to adhere to numerous guidelines and regulations set forth by regulatory bodies like the U.S. Food and Drug Administration (FDA). One such critical regulation is the Quality System Regulation (QSR) in 21 CFR Part 820, which mandates manufacturers to establish and maintain proceduresContinue reading “Unraveling the FDA’s Quality System Regulation (QSR) for Medical Device Manufacturers”