ABSTRACT
This chapter provides an overview of Verification and Validation (V&V) for embedded software in medical devices. It discusses verification and validation concepts such as planning, test development, and test execution. The initial planning of V&V is documented in a Software Verification and Validation Plan (SVVP). The SVVP describes the verification and validation life cycle, gives an overview of verification and validation, describes the verification and validation life cycle activities, defines the verification and validation documentation, and discusses the verification and validation administrative procedures. The verification and validation overview describes much of the project management details that must be addressed in order to perform the verification and validation functions. Each verification and validation phase has its activities and documentation that is associated with it. For Unit, Integration, and Software Validation test phases, typically there are test plans, test procedures, and test results/reports. The validation of the must cover the intended use of the test system.
