The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

by Amiram Daniel and Amiram Daniel and Edward Kimmelman

Book Overview

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 documents.This second edition also addresses a number of additional topics, such as the incorporation...

• Format: Hardcover
• Language: English
• ISBN: 0873897404
• ISBN13: 9780873897402
• Release Date: June 2008
• Publisher: ASQ Quality Press
• Length: 336 Pages
• Weight: 1.45 lbs.
• Dimensions: 0.8" x 6.0" x 9.0"