Compiling an abundant catalog of the essential criteria and methods for the design of medical devices, this comprehensive reference supplies insights into a rapidly evolving field-spanning practical knowledge, field tracking, valuable timesaving techniques, and the latest innovations. Reviews current regulatory and standards issues, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives Foreseeing a variety of concerns and obstacles, the Handbook of Medical Device Design identifies how to determine and document customer needs and device requirements establishes reliability and quality metrics for the duration of the product development cycle compares international regulations and standards, in Europe, Canada, Japan, and Australia illustrates electrical, mechanical, hardware, software, and industrial design considerations discusses biocompatibility, safety/risk analysis, third-party certification, technical documentation, translations, and life-cycle costs of implantable equipment thoroughly examines manufacturing processes such as quality system regulation and preparation for the quality system audit and more Includes useful appendices of tables and a glossary Written by experienced practitioners and authorities in the field, the Handbook of Medical Device Design is a necessary and worthwhile reference and guidebook for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project managers; biomedical technicians, medical device purchasing personnel; and upper-level undergraduate and graduate students in these disciplines.