Hey Lamiaa,

Good discussion question. I agree with all of the points on here. I just wanted to add also, that for a medical device, not following design controls can result in severe safety issues. It can cause numerous medical problems in patients as well as death in some cases. The reason that we have stringent design controls is to minimize patient harm. We create medical devices in order to help people, rather than cause more harm than good. Therefore, we need to be careful in following control guidelines, no matter how tedious or difficult they are.

-Zohour