The Agile approach has become widely accepted over the past couple of decades. However, in the heavily regulated medical product development field, the validity of Agile practices long remained controversial. This question is no longer at issue—rather, the question now is how development teams (and companies) can be Agile and still satisfy their regulatory requirements. Nancy Van Schooenderwoert will present highlights from several case studies that illustrate how Agile companies have found ingenious ways to maximize both quality and flexibility. These lessons apply to other industries where the presence of risk too often leads to paralysis. This presentation is based on the book Agile Methods for Safety-Critical Systems: . . .