Risk Management

Abstract Biomedical engineers strive to develop devices that are both effective and safe. Risk management is an essential skill that all medical device developers should understand and use aggressively to minimize any potential harm to patients and operators of the device. Risk management is the systematic application of policies, procedures, and practices to the tasks of identifying, analyzing, controlling, and monitoring risks associated with a device. Multiple techniques exist that can be used to conduct risk analyses and estimation such as hazard analysis (HA), failure modes and effects analysis (FMEA), and fault tree analysis (FTA). After risk analyses and evaluation for acceptability is conducted, risk control measures are selected and implemented. These risk control measures should be verified for effectiveness. Analysis of the remaining risk after implementation of the risk control measures should be conducted and the overall acceptability of the residual risk determined. Clearly, the benefits of the device should outweigh the residual risks in order to move forward with the development of the device. An international standard, ISO 14971:2000, exists that provides a straightforward description of how to establish an effective risk management process. This chapter provides an overview of the risk management process described in that standard and the documentation that is required. Application of risk management throughout the product development process will help the company to anticipate failures, make safer products, and minimize liability exposure.