Handbook of Medical Device Design

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, this handbook identifies how to determine and document customer needs and device requirements. Italso establishes reliability and quality metrics for the duration of the product development cycle. Topics include software standards and design, product requirements, hazard and risk analysis, biocompatibility, verification and validation, intellectual property, and analysis of test results and field data. According to E-Streams, “…Biomedical and engineering libraries would benefit from this addition to their reference collections.”