Agile methods promise faster development of medical devices but at the peril of jeopardizing regulatory compliance. Learn about the four key rules to follow to ensure you don’t sacrifice compliance in order to take advantage of agile methods. This presentation will describe how agile methods can lower risks, improve quality, and shorten time to market for medical device development. The presentation will cover the basic principles behind agile and lean methods and important adaptations needed for the particular needs of medical device companies. We will illustrate the methods with a comparison of two product development teams—one following a traditional approach and the other following an agile-lean approach. The presentation will conclude with a discussion of how to modify design controls, risk management, and other quality system procedures to support agile-lean product development.