Design quality--the key to product success.

Design control represents the essential difference between classical and modern quality assurance. Not only the product characteristics but also the basic product quality are determined during the design phase, and it is here that costly errors affecting the ultimate success of a product are avoided. These can be self-determined activities, requiring no intervention by third parties. In this article, the author urges medical device manufacturers to ensure product quality by implementing a design control from the very inception of a product.