Handbook of Medical Device Design

"a worthwhile reference and source. . ..Biomedical and engineering libraries would benefit from this addition to their reference collections."---E-Streams

• Standards and regulations: FDA regulations; preparing an FDA submission; European standards and regulations; the medical device directives; the basics of ISO 9001; design of medical devices for the Canadian market; Pacific Rim standards and regulations; overview of software standards. Determining and documenting requirements: defining the device; documenting the product requirements; medical device records. The design phase: hazard and risk analysis; hardware design; software design; human factors engineering; biocompatibility; reliability assurance; product user guides; translation - it's a small world after all; liability; intellectual property. Verification and validation: testing; overview of verification and validation for embedded software in medical devices; software verification and validation; reliability evaluation; analysis of test results. The manufacturing/field phase: quality system regulations and manufacturing; configuration management; the quality system audit; analysis of field data. Appendices: Chi Square table; percent rank tables.