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Design controls for the medical device industry

Author: Marie B Teixeira; Richard Bradley
Publisher: New York : Marcel Dekker, ©2003.
Edition/Format:   Print book : EnglishView all editions and formats
Summary:

Contains guidelines that enable readers to prepare for an FDA audit; and, identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies. This book also enables  Read more...

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Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Marie B Teixeira; Richard Bradley
ISBN: 082470830X 9780824708306
OCLC Number: 50291199
Description: x, 242 pages : illustrations ; 23 cm
Contents: 1. Overview --
2. Design and development planning --
3. Design input I --
4. Design input II --
5. Design outputs --
6. Design review --
7. Design verification --
8. Design validation --
9. Process validation --
10. Design transfer --
11. Design changes --
12. The design history file --
13. Questions to expect in an audit --
Appendices A-J --
Index.
Responsibility: Marie B. Teixeira, Richard Bradley.
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