The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition

Name: The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
Price: 83.06 USD
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4.3 of 5 Stars: Health & Medical Law - The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition

$83.06

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Description

Book Synopsis: 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 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 organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is:

A verbatim statement of the QSReg requirement.
A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.
Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg.
Excerpts from various FDA guidance documents related to quality management systems.
A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances.
Authors notes giving guidance derived from the authors sixty years of regulatory compliance experience.

This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.

Details

Are you a manufacturer of medical devices looking for the most comprehensive guidebook to navigate the intricate world of FDA and Worldwide Quality System Requirements? Look no further! Introducing the FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition.

This second edition has been meticulously crafted to include all the requirements and guidance you need to ensure regulatory compliance. It covers the Quality System Regulation (QSReg), ISO 13485:2003 standard, ISO/TR 14969:2004 guidance document, and even incorporates the valuable insights from FDA and Global Harmonization Task Force (GHTF) guidance documents.

But that's not all! Our updated guidebook also tackles additional topics that are highly relevant to the modern medical device industry. It delves into risk management integration, QMS issues related to combination products, key process interactions within a QMS, effective presentation and advocacy during FDA inspections and third-party assessments, and even future FDA compliance and standards activities.

What sets our guidebook apart is its organized structure, meticulously aligned with the requirements in the QSReg. Each section delivers a verbatim statement of the requirement, a comparison with ISO 13485:2003, insightful excerpts from FDA responses and guidance documents, relevant guidance from ISO/TR 14969:2004, and the author's valuable industry expertise.

This comprehensive and up-to-date guidebook is a must-have for all medical device manufacturers. It provides the necessary support and information to ensure your quality system practices meet the stringent regulatory demands. Use it as a companion to the regulations and standards themselves, and enhance your understanding of the specific processes and activities within your QMS.

Don't miss out on this invaluable resource. Stay ahead in the complex world of medical device regulations and boost your compliance with the FDA and Worldwide Quality System Requirements. Get your copy now and unlock success today!

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