ABSTRACT
The design and functional complexity of medical devices have continued to progress since the second edition of this book. As device functionality becomes more intricate, concerns arise regarding efcacy, safety, and reliability. Both the user and the patient want the device to operate as specied, perform in a safe manner, and continue to perform over a long period of time without failure. To be successful, the designer and manufacturer of medical devices must ensure that all devices function according to specication and are reliable.
