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Chapter 4: Software for Medical Systems - Pg. 147

CHAPTER 4 Software for Medical Systems Jeff Geisler 1. Introduction Safety has long been a prominent concern with food, drugs, and devices. Medical devices are regulated by government in every important economy in the world. With the invention of the computer and the ability to embed computers and software in devices, it was only natural that software would become important in medicine. Sometimes the software is a medical device, such as image processing software making a breast cancer diagnosis from a mammogram would be. As software has gained more functionality and touched safety, such as in software systems that keep patients alive, regulatory bodies worldwide have gradually come to realize the importance of regulating software and its construction as well as the more traditional scope of regulating manufacturing processes.