Description: FDA and Worldwide Quality System Requirements Guidebook for Medical Devices 2nd Edition 2008 Hardcover HCFDA and Worldwide Quality System Requirements Guide for Medical Devices, Hardcover by Daniel, Amiram; Kimmelman, Ed, ISBN 0873897404, ISBN-13 9780873897402, Like New Used, Free shipping in the USHow have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485:2003 standard and the ISO/TR 14969:2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes and update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs. Annotation ©2008 Book News, Inc., Portland, OR ()In "like new" preowned condition.
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Book Title: FDA and Worldwide Quality System Requirements Guidebook for Medic
Educational Level: Adult & Further Education
Publication Name: Fda and Worldwide Quality System Requirements Guidebook for Medical Devices
Language: English
Publisher: Quality Press
Publication Year: 2008
Subject: Medical Law & Legislation, Instruments & Supplies, Quality Control
Type: Textbook
Author: Ed Kimmelman, Kimberly A. Trautman, Amiram Daniel
Subject Area: Law, Business & Economics, Medical
Format: Hardcover
