ABSTRACT
Chapter 2 mentioned that design verification is a confirmation that the design input requirements have been fulfilled by the design output. It also stated that before the FDA mandated design control to provide a sense of formality and structure, common sense drove some companies to adopt such concepts as “engineering pilot,” “design pilot,” and “engineering built” to verify design output. This chapter focuses on medical device reliability verification. Table 10.1 illustrates a typical design-reliability verification activity report. It clearly shows that the design output meets or exceeds the design input from a reliability point of view.
