Download or read book Handbook of Medical Device Design written by Richard C. Fries and published by CRC Press. This book was released on 2000-09-14 with total page 798 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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