If a company strives to just make the standards of regulations, then it would follow that the product would not be of the best quality. Quality standards within many medical device companies however tend to surpass the standards of regulatory bodies for a variety of reasons. There is a marketing point to not only meeting regulatory standards but blowing past them: it can scream excellence for a device, making it more appealing to a customer. As mentioned above, quality can also sometimes be dictated by other competitors, rather than regulating bodies. Talking along the lines of excellence, when a company can guarantee a certain degree of quality it is a major selling point to have over a competitor. Therefore in order to beat that aspect of competition, quality standards can be driven by trying to beat the standards of competitors. Taking all of these things in mind, I don’t think having government regulations is something that would really stifle quality of products. It may cause challenges in designing a product, but since quality can oftentimes be driven by factors other than regulatory bodies, I don’t really see it causing a degradation in device quality.