The centrality of quality management in medical device production cannot be overstated. For that reason, the production of medical devices is heavily regulated across the world, falling under the jurisdiction of various national and international bodies, such as the U.S. Food and Drug Administration and the European Commission. To help companies comply with this international…
Medical devices sold in the United States are subject to some of the most stringent manufacturing requirements in the world. Guidelines for every stage, from establishment registration to labeling, are detailed in U.S. Food & Drug Administration (FDA) regulations. Inspections are regularly conducted to enforce FDA regulations, and fiduciary penalties are levied for noncompliance. In…
The story of medicine is the story of innovation. We’ve come a long way, from biles and humors to germ theory to modern inoculants, antibacterials, and diagnostic and corrective devices. Our knowledge constantly increases. New discoveries, new plastics for syringes, new composites for prosthetics—sometimes these are best built with new tools. At the same time,…