This book presents the framework and interconnections of the development, conformity assessment, and verification of medical devices. It describes the hurdles and pitfalls that a manufacturer must overcome and the design options available to bring medical devices to the European market. The author explains which factors determine risk perception and which safety objectives must be met. He outlines how the risk management process should be implemented, including risk analysis, assessment, control, and monitoring, to ensure the safety and conformity of medical devices. The book is now available in its second updated edition. Aspects of medical software and quality management have been given greater consideration, and the new medical device regulations regarding conformity assessment and market approval requirements are addressed.