Last semester in medical device course, I worked on a medical device project called Automated CPR machine and my role was to analyze the risk. The most common risk in this device is bone breakage (sternum, and ribs) and organ damage expected during CPR process because the worry of causing a break shouldn’t deter people from helping someone in cardiac arrest. Risk can be control or mitigate by providing appropriate employee training before using the device. In the U.S, current CPR recommendation call for chest compressions to be at least five centimeters (about two inches) deep, at a rate of 100 per minute or faster. There are many factors to considered for bone breakage such as age, weight, gender and if CPR performed by someone other than a doctor are more likely to end up being bone fracture. The way to measure the risk must be weighed against the expected benefits, including the type of benefits, the probability of the benefits, and also account the severity of the disease device is intended to treat. All of those risks can be verified by design validation and verification process and human factors testing.