The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include
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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.