Author: Amiram Daniel and Edward Kimmelman
Edition: 2
Binding: Hardcover
ISBN: 0873897404
Edition: 2
Binding: Hardcover
ISBN: 0873897404
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
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.
[ Ships Daily ] Condition: Good[ Underlining/Highlighting: NONE ] [ Writing: NONE ] The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition By Amiram Daniel and Edward Kimmelman ISBN: 0873897404 Edition:second Publisher: ASQ Quality Press Pub Date: 6/6/2008 Binding: Hardcover Pages: 336
This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities.
The FDA and Worldwide Quality System Requirements Guidebook for Medica
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices provides essential information regarding FDA regulation for medical devices and international quality system requirements ( ISO 9001 and ISO / DIS 13485 ).
How 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 an update their material to include such topics as the incorporation of principles of risk
Categories: Medical instruments and apparatus industry. Contributors: Amiram Daniel - Author. Format: Hardcover
Categories: Medical instruments and apparatus industry. Contributors: Amiram Daniel - Author. Format: Hardcover
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