Get the latest information on risk management concepts and practices for the medical device industry and learn how to plan your organization's risk management and analysis program. Understanding risk analysis is essential to anyone in the medical device industry-this is a focus of the design control requirements in FDA's Medical Device Quality System Regulation and ISO 14971: Application of Risk Management to Medical Devices. Risk analysis has been an essential requirement of the European Union (EU) Directives for medical devices as applied by EN 1441-Application of Risk Analysis to Medical Devices. Learn how to manage a process associated with the identification, analysis, evaluation, and control of different types of risk in the medical device and diagnostics industries. Class discussions cover the use of failure mode and effects analysis (FMEA) and fault tree analysis (FTA) as methods of conducting risk analysis, including predictions and determining approaches to reliability and safety analysis. Also covered is the application of these tools to product design and manufacturing processes.