I’d also like to add on the importance of risk analysis for a Design Control System. Overall, everything boils down to the well-being of the people, and that is why the FDA needs to ensure that the product performs as promised, and is safe to use. However, anything can happen depending on the type of medical product you are using. For instance, a hip implant will be beneficial for a patient who has a bad hip, but its possible that the implant can cause some fatigue over time. For these reasons, its necessary that a risk analysis is developed so that the FDA is aware of the possible risks that can occur. Also, the risk analysis will tell us what procedures will be taken to prevent or stop these issues from occurring. Not every product is perfect, and its essential to know that there is a plan to fix any issues that may arise.