The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices by Kimberly A. Trautman |
by David Muchemu
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by Gordon Harnack
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition by Amiram Daniel and Edward Kimmelman |
by Jack Kanholm
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Product Description
This is a focused and well-organized book with in-depth interpretation of ISO 13485 (EN 46000) requirements. It identifies and explains 99 distinct, auditable requirements that must be implemented to pass the certification audit. Every requirement is systematically explained with regard to interpretation, procedures and records, and examples of how auditors will verify conformance. In essence, the book reinterprets the standards into a list of specific actions that need to be taken to achieve conformance, and explains how to implement them in the organization. The list of all requirements discussed in the book is provided under the Table of Contents in the Book Information menu on the left side of this page.
From the Publisher
This ISO 13485 (EN 46000) series is the latest addition to our publications on quality management standards. In 1992 we published Jack Kanholm's ISO 9000 series and in 1995 his QS-9000 series. Both established themselves as the reference of choice for understanding, interpreting and implementing these standards - selling over 90,000 copies. The ISO 13485 (EN 46000) series is very similar in its structure and approach. Based on the success of his previous books, we also published recently Jack Kanholm's ISO 14000 series on environmental management standards.
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