Design controls are not being used as an aid during medical device product development. Design controls are being viewed as a checkbox item — something you have to do, and seldom something you want to ...

FDA's quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the ...

Medical device companies have long struggled with understanding design controls and making sure they are implemented correctly to ensure regulatory compliance. Jon Speer Design controls have been a ...