If you are developing a medical device for the U.S. market, you first need to determine how your device will be classified by FDA. If you do not know the FDA classification, I recommend you go check ...

Congratulations! You’ve had a great new idea for a world-changing medical device. You’re about to start the exciting journey of medical device product development. Medical devices aren’t like other ...

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 ...