"LIFE-CYCLE" APPROACH TO SOFTWARE DEVELOPMENT WILL AID COMPLIANCE WITH GMP DESIGN CONTROL REQUIREMENTS, FDA'S MIDGETTE TELLS HIMA
This article was originally published in The Gray Sheet
Executive Summary
Device manufacturers should adopt a "life-cycle model" for software development as part of a strategy for complying with the design control requirements of FDA's final good manufacturing practice rule, according to William Midgette, deputy chief of the Medical Electronics Branch in the agency's Office of Science and Technology.