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Lehigh University - FALL 2010

Textbooks for Course CHM 428

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 ()
by Gordon Harnack
Paperback, 289 Pages, Published

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 —


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