IEC 62304 is an international standard (hereafter referred to as the Standard) that specifies software development life cycle processes to improve the safety of medical devices. It defines a series of activities and tasks that are required for medical device software engineering. We will discuss how MathWorks tools for Model-Based Design, which have been used to create high-integrity software, can be used to create control system and signal processing software in a manner compliant with the Standard.