Design control is not required in EU, but I would say it is very helpful to have it, EU do have the Design Dossier/ Technical Files which king off go along with Design Control but it is not the same document as design control. Design control is very important document to have it if it required by the EU medical device regulation agency or not because you wana catch any problem possibly the product might have before it launch in the market, because if someone get hurt by your product your company will loose a lot of money. So it is better to invest a little more time and make a DHF. So if we talk about comparing two philosophies I would say having the Design Controls is very important if some companies think it is not necessary step and we do not do it because it is not required then that companies will end up hurting it’s business at some point. And their is only the Pros to this their is no Cons, having everything documented DHF can help if something happen in the future and their is some improvement to make.