The ISO 14971:2012 risk management requirement is not clear because one cannot define” as far as possible.” The risk management team can find ways to mitigate, eliminate, prepare for risks which can have an economic effect on the medical device. Despite the economic toll on reducing the risks of a medical device, it is necessary to keep the safety of the user to the upmost importance. The company’s risk management team should layout a PFMEA which breakdown the risks and severity of each process in creating the medical device. Then they should determine ways to reduce the number of risks so that the product is safe for the user.