CAPA vs. Correction: When Does a Quality Issue Need More Than a Fix?
Every medical device company runs into quality issues from time to time. Sometimes a component might fail a test, while other times a supplier could deliver...
Does a Change to a Medical Device Require a New 510(k)?
Medical devices rarely stay the same after they receive clearance from the FDA. New breakthroughs, design tweaks, software updates, and manufacturing improvements happen all the time....