Handbook of Medical Device Design

by Fries; Richard C.

• ISBN13: 9780824703998
• ISBN10: 0824703995
• Edition: 1st
• Format: Hardcover
• Copyright: 2000-09-14
• Publisher: CRC Press

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

Table of Contents

Preface	v
Contributors	xvii
Section 1 Standards and Regulations	1
FDA Regulations	3	(1)
Richard C. Fries
History of Device Regulation	4	(1)
Device Classification	5	(4)
Registration and Listing	9	(1)
Good Laboratory Practices (GLP)	10	(1)
Good Manufacturing Practices (GMP)	10	(1)
Human Factors	11	(1)
Design Control	11	(1)
Software	12	(2)
The FDA Inspection	14	(1)
Dealing with the FDA	15	(1)
References	16	(5)
Preparing an FDA Submission	21	(1)
Richard C. Fries
Device Classification	22	(4)
The Traditional 510(k)	26