First, I’d want to make sure that everyone in the project understands what the device is, its purpose, its design, and how it will be processed. Once we understand the device and what is going to happen, we can then as a team decide together what we think the risks would be. Based on what we learned in lecture, we must consider the risks for the product, the product design and the manufacturing process. We will list risks accordingly based on product, product design, and manufacturing. Once the list of risks are determined we can move on to evaluating each risk by using the FMECA as suggested in lecture. Once evaluation is done, we will determine how to manage each risk based on its severity and whether we can accept it, avoid it, mitigate it, or go through transference. Once that’s figure out, we can begin to develop solutions for those risks that need attention.