ABSTRACT
Each period in the system life cycle must be controlled to maximize the likelihood that the finished computer system meets all requirements such as: quality, regulatory, safety, functional, non-functional, and so on. The Acquisition Process defines the activities of the acquirer, the organization that acquires a system, software product, or service. The regulated user gives up SLC control, but still bears the responsibility for the continued safe and effective performance of the medical device. The Development Process contains the activities and tasks of the developer. The process contains the activities for requirements analysis, design, coding, integration, testing, and installation and acceptance related to the computer systems. Software validation takes place within the environment of an established software life cycle. The software life cycle contains software engineering tasks and documentation necessary to support the software validation effort.
