Handbook of medical device designc

• Other Authors: Fries, Richard C. (Editor)
• Format: Book
• Language: English
• Published: New York Marcel Dekker 2001
• Subjects: Equipment and Supplies > Handbook > standards; Equipment Design > Handbook > methods
• Online Access: Click Here to View Status and Holdings.
• Physical Description: xviii, 774 pages illustrations 24 cm
• Bibliography: Includes bibliographical references and index
• ISBN: 9780824703998; 0824703995

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