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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition, by Amiram Daniel and Edward Kimmelman
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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.
- Sales Rank: #445432 in Books
- Brand: Brand: ASQ Quality Press
- Published on: 2008-06-06
- Original language: English
- Number of items: 1
- Dimensions: 9.25" h x 6.25" w x 1.00" l, 1.45 pounds
- Binding: Hardcover
- 336 pages
- Used Book in Good Condition
Most helpful customer reviews
2 of 2 people found the following review helpful.
Handy FDA guidebook
By Ramona Wright
This is a handy guidebook for any FDA related information on medical devices. This book was an easy read along with the information being easy to understand. This was a syllabus requirement for my class and it was easy to find on Amazon and cheaper to purchase here. All guidebooks should follow the format that these authors used to create it.
21 of 22 people found the following review helpful.
Basic Reference for 820
By mph
Steep price tag but worth it because - This is a good basic reference book for 21 CFR 820. It provides an outline of each requirement of the QSR with cross reference to and comparison with ISO 13485. It contains a matrix of 820 vs. 13485 with authors' notes that describe similarities/differences. It provides reference to the guidance ISO/TR 14969 which clarifies 13485. It also contains a section on process interactions, i.e., how CAPA interacts with Risk Analysis, etc. There is a chapter on Risk Analysis and information on Design Control. The comments to the QSR preamble are included and elaborated on which is helpful in determining the intent of law, useful for interpretation and application of the QSR . The authors offer useful guidance and some interpretation. All in all a good reference for new and/or practicing Quality Assurance staff, device managers, those seeking ISO medical device certification or improving their compliance in preparation for audits.
9 of 16 people found the following review helpful.
A must for medical device manufacturers, and anyone who must comply with these regulations.
By Midwest Book Review
Now published in a newly expanded and updated second edition, "The FDA Worldwide Quality System Requirements Guidebook for Medical Devices" is a complete and comprehensive reference for Quality System Regulation standards governing the use of medical devices. Now in a new and improved second edition, "The FDA Worldwide Quality System Requirements Guidebook for Medical Devices" addresses many newer topics such as risk management, efficiency, and compliance issues, and much more. Covering both American and international health standards, "The FDA Worldwide Quality System Requirements Guidebook for Medical Devices" is a must for medical device manufacturers, and anyone who must comply with these regulations.
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