Handbook of Medical Device Design

ISBN: 9780824703998 出版年：2000 页码：795 Fries, Richard C CRC Press

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.