Software is a critical component of any active medical device. No matter if the device is legacy or new, medical software V&V tends to be stringent and rigorous, leading to longer testing cycles. As product technology, ecosystem complexity, and the need to expand markets evolve, software v&v for medical devices is likely to become much more resource intensive.

Setting up a strong V&V team, processes, and practices that cover the whole product lifecycle takes time, capital, infrastructure, and specialized knowledge, which may hurt the manufacturer's bottom line. In addition to being tested for functionality, reliability, and usability, software must also meet strict regulatory requirements that change all the time.

It is paramount that a V&V practice delivers the confidence needed in the implementation plan and the certainty of seamlessly achieving milestones throughout the product lifecycle.