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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices Second Edition
Author: Amiram Daniel and Edward Kimmelman
This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance d...  more »
ISBN-13: 9780873897402
ISBN-10: 0873897404
Publication Date: 6/6/2008
Pages: 336
Edition: 2
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Publisher: ASQ Quality Press
Book Type: Hardcover
Members Wishing: 0
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