Software quality in medical devices-a top-down approach

The development of highly reliable software is key to the success of many of today's medical devices and instruments. The development of such software is achieved through a phased development process that starts with requirements and ends when the product reaches the market. Quality medical software is achieved by applying verification and validation techniques throughout he different development phases. Verification and validation (V&V) has successfully been applied to software in military, aerospace, and medical systems. Because applied V&V yields highly reliable software in the demanding medical environment, verification and validation techniques represent the leading edge in achieving solid medical software quality. V&V is a proven method for producing quality software. Verification assures that each time a step is taken in the software development process, testing is performed to ensure that the step was done correctly. Validation compares the final product to the original specification. A software-controlled device that does not perform as expected may be acceptable in some industries. In the medical device field, defect-ridden software could prove to be fatal.<>