Risk Management for Medical Devices in Compliance with EN ISO 14971

Abstract

As a medical device manufacturer, one is often confronted with questions regarding the correct application of risk management for medical devices. For example, it is important to know from the outset which regulations or legal bases apply to risk management. For the implementation of the risk management process, it is important to know which phases it has to go through and which methods and tools are helpful in the implementation. And, of course, it is also important to know which documents have to be created and which prerequisites have to be fulfilled in order to be able to perform a risk assessment, for example.

To answer these questions, this chapter highlights the relevant regulations and laws for risk management in the development and manufacturing of medical devices. Furthermore, the risk management process in the life cycle of a medical device is presented, and the procedure for its implementation is outlined. In addition, the individual elements of the risk management process are described and discussed in detail. All documents that are considered as evidence of the establishment of a complete risk management process are presented, and their necessary content is shown. The most commonly used risk management methods, such as fault tree analysis, Ishikawa diagram, and failure mode and effects analysis, are described, and the strengths and weaknesses of these methods are discussed. Finally, the use of knowledge-based software systems for risk management is discussed, as these software systems are increasingly coming into focus to enable knowledge management in risk management.