Applied Human Factors in Medical Device Design

Applied Human Factors in Medical Device Design, Second Edition describes the human factors practices and methods used for the design of medical devices. It begins with an overview of all the essential practices and processes an engineer needs to understand and implement when carrying out medical device design, referencing the in-depth descriptions and case studies of the relevant chapters that follow. Written from an experienced practice perspective, it explains each method, describing why it is important, its potential impact, when it's ideal to use, and related challenges. Emphasis is placed on good design and usability testing. Also discussed are country specific regulatory guidelines and international standards. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation.

• Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process globally with emphasis on meeting the US and EU requirements.
• Explains technology development and the application of human factors throughout the development process
• Covers FDA, EU and MHRA regulations
• Includes case examples with each method