Interestingly, as a brand new development which I have not had time to update for the course, Design Controls are now in fact required virtually everywhere in the world. The new EU Medical Device Regulation (MDR) specifically looks for a quality system that follows ISO 13485:2016. If you look at ISO 13485:2016 (which itself is still very new), you will see it is virtually a 95% copy of 21 CFR 820, and under the product realization sections you have…. guess what? Design Controls.

So now, any regulatory system, in any country, that requires or accepts the use of ISO 13845:2016 as part of its process now requires Design Controls. It’s a big deal.