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Lehigh University - FALL 2010 | ||
Section D10 | ||
Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration (99th Edition) by Gordon Harnack Paperback, 289 Pages, Published 1999 ISBN-10: 0-87389-455-3 / 0873894553 ISBN-13: 978-0-87389-455-5 / 9780873894555 ... Thompson Publishing Group, Washington, D.C. 5. The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Kimberly A. Trautman, ASQC Quality Press, 1997. 6. The ISO 9000 Handbook, 2nd Edition, edited by Robert W. Peach, CEEM Information Services, Fairfax, VA 1994. 483 — |