ABSTRACT
Why is there never enough time to develop a product correctly, but always enough time to do it over?
Anonymous
An error doesn’t become a mistake until you refuse to correct it.
Orlando A. Battista
Earlier chapters covered reliability, which, with proper design, should imply safety. This chapter will cover the legal aspects of liability, and to tie these issues together, a number of legal cases will be covered, with the intention of informing the reader regarding items that must be considered in the design of safe medical devices and systems. The cases will also inform as to the readers’ possible future as a forensics or accident investigation engineer.
