I agree with all of the participants in this post regarding Dr. Simon’s class. This is my second semester as Masters in Biomedical Engineering and also second time taking a class with Dr. Simon. Previous semester, in project management class, I’ve learned a lot in terms of FDA regulations and project management. During this course, it was more of executing the items learned in previous semester. I understand that technical engineering classes teach the skills, however it is barely used while working in the professional work force. One of the exciting part of this class, is the DHR project. We’ve learned the entire process of how to effectively launch a successful medical device product in the market. All in all, this is a great class as it gives one the complete understanding of design controls and ISO 14971, risk management within the medical devices.