The Food and Drug Administration (FDA) has requirements for medical device manufacturers to establish and maintain a quality system for their medical device(s). The requirement for a quality system does not necessarily introduce new concepts, but applies existing quality concepts to design, development, manufacturing, distribution and use of medical devices. This white paper from EMMA International – an associate member of AdvaMed – covers the history and evolution of quality systems and their application to medical devices. A quality tool that could be well applied to the specific area of design controls, Quality Function Deployment (QFD), is a focus of this paper.