Chapter 17 - Risk management

Abstract

Risk management activities are performed and completed for new medical devices or changes to existing ones by the development team during development. They are documented and approved before product launch. Risk management activities are also performed to assess design modifications to existing products and processes and are documented and approved before introducing the modified product to the market. Management's decision to accept a risk should be deliberate, and the criteria for the decision should be documented. \ From design, engineering, testing, and beyond, a medical device risk management process is an integral part of every phase of the project. Whether manufacturers seek to design a new product or improve an existing one, the medical device risk management process must be rigorous, especially if the manufacturers are trying to gain FDA marketing approval and clearance. If a medical device risk management process is not done correctly, this can lead to the project lacking specific mitigations.