ABSTRACT
The motivation for controlling the process of designing medical devices is twofold. First, the obvious motivation is that the FDA included such control as part of its Quality System Regulation. The second and better motivation is that such a set of disciplines can improve business for any manufacturer. This chapter aims to impart an understanding of what the FDA and its Center for Devices and Radiological Health (CDRH) are seeking with design controls and validations. At the same time, the chapter addresses the business benefits beyond being in compliance with the regulation.
