Features
- Cover Type: Paperback with 368 pages
- Published by: ASQ Quality Press March 2006
- Written in: English
- ISBN 10 Number: 0873896742
- ISBN 13 Number: 978-0873896740
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Book Dimensions:
8.8 x 6 x 1 inches
- Weighs: 1.2 pounds
A reader in Houston, TX
The author describes adding to the bottom line. I am buying this book for my developers, SQA's, and managers.
Book Description
This book provides information and recommendations to help regulatory affairs and quality managers and consultants of
software medical device design and development organizations navigate the complex course of regulatory compliance, operational excellence, product quality, and customer satisfaction to create an effective and efficient quality system.
software organization executives, functional managers, and other interested coworkers can also utilize this book to secure a general understanding of the subject matter.
Many consulting firms, industry associations, and educational institutions present regulatory and quality training opportunities to regulatory and quality students and professionals. However, most training events focus on specific topics or requirements, such as ISO 9000, FDA Quality System Regulations, Six Sigma, vendor qualification, and
software design control. Regulations and standards typically provide concise statements of requirements, but not much more. This book fills that gap in information available to regulatory and quality professionals in the
software medical device industry. The resultant operational management system outlined in Appendix A, the
software Medical Device Quality System Guidelines, provides these professionals with recommendations and considerations for implementing the potentially duplicative requirements in a manner that reduces the bureaucracy of the system and adds value toward satisfying the organization's objectives.
Included on a CD-ROM accompanying the book is Appendix A,
software Medical Device Quality System Guidelines.
Reader ReviewsI decided to buy this book based on a review by Alan Madick: "Safe and Sound Software focuses on product quality, an aspect of system development that is often overlooked but is critical to the software medical device market. The book is well organized and presented so as to drive home the importance of quality in a medical system. ... The style of this book is consistent and easy to read. Within each chapter, the author provides relevant definitions, along with both recommendations and mandatory processes to follow as software is designed, coded, tested, and implemented. It provides ample discussion on risk management, which is critical to a business where risk and mitigation play such a prominent role. It also provides the reader with an overview of some of the more influential regulatory and compliance guidelines, such as FDA, the Sarbanes-Oxley Act, and a myriad of international standards that must be considered when marketing these products to the world. Finally, the book provides a nice recap of the quality system guidelines." My objective was to provide a complementary guide to my software testers and the first impression that I got is that this is a valuable resource.
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