ABSTRACT
Software engineering has both managerial and technical aspects. There are certain fundamental activities that are necessary for each of these aspects. Executing these fundamental activities well is the key to successful medical device software design. As in hardware design, specifying the software requirements, creating a sound software design and correctly implementing it are difficult intellectual challenges. As with development process models, there are a number of basically different software design methods with many variations. They each provide criteria for expressing and refining the principles of good software design. Most software design methods take one of three approaches: top-down structured analysis and design, data-driven analysis and design, and object-oriented analysis and design. Programming languages are the tools used to transform the software design into executable instructions for the computer. The goal of software configuration management is to control and track changes in the software to assure that nothing is lost or destroyed.
