5310467
9780873896740
"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 use this book to secure a general understanding of the subject matter."--BOOK JACKET.Thomas H. Faris is the author of 'Safe and Sound Software: Creating an Efficient and Effective Quality System for Software Medical Device Organizations' with ISBN 9780873896740 and ISBN 0873896742.
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