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. It establishes reliability and quality metrics for the duration of the product development. The 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!