As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. The second edition of Reliable Design of Medical Devices presents the basic concepts and the major issues involved in the design of medical devices, updating the information to stay at the forefront of developments in the industry. This edition includes new topics such as Six Sigma philosophy, electronic signature, material selection and biocompatibility, and quick response manufacturing. The book helps manufacturers implement a reliability assurance program while conforming to current regulations and will also help purchasers formulate effective vendor evaluation methods.