ISO 14971 requires a specific risk management process for medical device companies to follow. The major phases are risk analysis, risk evaluation, risk control, residual risk evaluation, risk/benefit analysis, and evaluation of overall residual risk acceptability. A risk management report is created to organize and summarize all of the risk activities. The risk management of a medical device is a total product life cycle process. This means that even after the device exits product development, the risk management records must be keep up to date. Post production events such as complaints, product feedback, non-conformances, etc are some examples of updates that can be made to the report.