For those working in the development and use of medical devices, presents practical knowledge about biomedical technology and regulations, techniques for improving the methodology of designing and manufacturing medical devices, and ways to improve the functionality and reliability of the devices themselves. Chapters in the first section are devoted to standards and regulations: FDA regulations and submission preparation; European, Canadian, and Pacific Rim standards and regulations; medical device directives; basics of ISO 9001; and software standards. Subsequent sections discuss in detail determining and documenting requirements, the design phase, verification and validation, and the manufacturing/field phase. The editor and the contributors are veteran reliability engineers. Annotation c. Book News, Inc., Portland, OR (booknews.com)
