Handbook of Medical Device Design

Richard C. Fries

September 14, 2000 by CRC Press
Reference - 794 Pages
ISBN 9780824703998 - CAT# DK1664

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Summary

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

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