The regulations in the USA vs EU are stricter in terms of documentation. With that being said it seems that the FDA tends to expatriate the companies with documentation where EU is lenient. However, in terms of actual processes I believe Design Controls should be applied to every country that works in the medical device industry. These controls help to keep users and patients safe that’s as simple as it can be put. I raise a question. With less regulatory rules do products still have excellent quality? With less controls do more medical devices become quicker to produce then the US?