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

by Amiram Daniel and Edward Kimmelman

Download The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition ePub
  • ISBN 0873897404
  • ISBN13 978-0873897402
  • Language English
  • Author Amiram Daniel and Edward Kimmelman
  • Publisher ASQ Quality Press; 2 edition (June 6, 2008)
  • Pages 336
  • Formats lrf mobi rtf txt
  • Category Medicine
  • Subcategory Medicine
  • Size ePub 1319 kb
  • Size Fb2 1302 kb
  • Rating: 4.7
  • Votes: 798

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.

This is a handy guidebook for any FDA related information on medical devices

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. 2 people found this helpful.

Details (if other): Cancel. 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 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?

Электронная книга "The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices", Amiram Daniel.

Электронная книга "The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices", Amiram Daniel. Эту книгу можно прочитать в Google Play Книгах на компьютере, а также на устройствах Android и iOS. Выделяйте текст, добавляйте закладки и делайте заметки, скачав книгу "The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices" для чтения в офлайн-режиме.

Bibliographic Details. Title: The FDA and Worldwide Quality System.

For each substantive requirement section there is: A verbatim statement of the QSReg requirement.

Published in: Education.

Quality Systems Regulations - Продолжительность: 41:44 USC Department of Regulatory and Quality Sciences .

Quality Systems Regulations - Продолжительность: 41:44 USC Department of Regulatory and Quality Sciences Recommended for you. 41:44. Fast - Josh Kaufman - Продолжительность: 23:20 The RSA Recommended for you. 23:20. I turn Fridge Compressor into Working Engine - Продолжительность: 23:35 Lets Learn Something Recommended for you. 23:35. Страна: США. Безопасный режим: выкл.

International Standard Book Number (ISBN): 0873897404 (alk. paper). System Control Number: (OCoLC)ocn214066132. System Control Number: (OCoLC)214066132. Rubrics: Medical instruments and apparatus industry Law and legislation United States Quality control. Download now The FDA and worldwide quality system requirements guidebook for medical devices compiled and written by Amiram Daniel & Ed Kimmelman. Download PDF book format. Download DOC book format.

ISBN13:9780873897402. Release Date:May 2008.

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


Samugul
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.
skyjettttt
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.
Runehammer
Excellent, Thanks
Vetalol
The book was a very handy guide to help put FDA and ISO requirements for medical devices in perspective, in its day. However, this edition is based on obsolete versions of FDA21CFR Part 820, ISO14969 and ISO13485. Use of this book now could get you in trouble!!