Risk Management is required by the ISO 14971, and must be completed by the company. The company will go through the cycle of assessing, evaluating, managing, and then measuring the risks. The company is responsible for taking all aspects of the product into consideration for risk analysis, such as the product itself, the design, and the manufacturing process. For each part of the cycle (assess, evaluate, manage, measure) comes with specific methods on how to develop a solution for each risk listed. For instance, once you come up with a list of risks, you must evaluate them using FMECA, and then manage them either by avoidance, mitigation, acceptance, or transference.