The manufacturing of a product should only be allowed if precision and accuracy are guaranteed. When some doctor or medical personnel goes to use a device they should be utterly sure that it is going to work exactly how they are expecting a device to work. Products are seen to have a huge mark up if you look at just the overhead cost of the products material. This up charge is also to cover the expenses of all the products that are discarded for not being able to meet these regulations. Devices are checked continuously throughout their production to make sure these goals are met and maintained