ISO 14971 defines risk management as a systematic life cycle process to identify, estimate, control and evaluate risk, where risk is defined as the combination of severity of harm (to people, property or environment) and probability of harm occurrence. A set of activities and records are required in order to comply with the standard.


Safety assurance case is a method for effectively communicating why a safety goal (e.g. system is safe for its intended use) is met or a safety claim (e.g. overall residual risk is acceptable) is fulfilled. A safety assurance case is a body of argument that the methods and results of risk management are adequate, sufficient, supported by evidences. It asks whys and demands explicit and logically connected information to be included in the risk management file. As a result, safety assurance case development stimulates critical thinking and drives improvements in risk management. When being applied proactively, safety assurance case becomes an effective method to challenge the logic, results and process of the risk management and yield more streamlined, thorough, and more evidence based risk management practices, and assure medical device safety.


GessNet™ TurboAC™ software provides a powerful all-in-one environment to automate, streamline risk management activities, maintain records and results through the product life cycle for compliance with ISO 14971 and FDA requirements, and automatically integrate safety assurance case method into the risk management process as needed.