I am currently doing capstone 2 at NJIT, we definitely do the testing of our design but we do not make the clinical trial Protocol. My project is to make the control cortical Impact device which is used to make an traumatic brain injury on the rat. So in this project we have created the test plan to test hardware and software requirements and we also have to perform the demo of our device to show that it working but we are not allowed to do it on real rat. We do the IRB approval document as an assignment for the class but we do not do not submit it. And we also do the assignment to classify our device in terms of class 1, class 2 or class 3 but as I said it is an assignment so we do not go to a complex level that we have to fill out the 510(k) or executed the clinical trial protocol.