A product is only as good as the factory it is built in. This proves to be especially true in terms of medical devices. From a business perspective, meeting compliance regulations is one of the greatest challenges medical manufacturers struggle with. This is not to say it is always difficult to do (though it can be with such complicated products), but it is a long, time-consuming, and expensive process. Before any medical product can go out to the market, the manufacturer must be able to make sure, and prove, their device meets government regulations. One of the steps in this process is ensuring their factory equipment is meeting IQ/OQ/PQ protocol.