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New Edition on the Reliable Design of Medical Devices Now Available from CRC Press
Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices.
Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT).
What’s New in This Edition
Updates throughout, reflecting changes in the field
An updated software development process
Updated hardware test procedures
A new layout that follows the product development process
A wfavv list of deliverables needed at the end of each development phase
Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.
Praise Reliable Design of Medical Devices
"This book focuses on an important topic ... that engineers need to understand in all of its aspects—philosophy, design, and testing and evaluation. They also need to know how they fit in to the larger picture (manufacturing, packaging, etc…). This book provides both an overview of those facets, along with details to implement them. It is thus a valuable resource for students, researchers, and industry [professionals]
—Jon Sensinger, Rehabilitation Institute of Chicago, Illinois, USA
About the Author
Richard Fries, PE, CSQE, CRE, is president of ISORel, Inc., a consulting firm located in Fitchburg, Wisconsin. He is a licensed professional engineer in the state of Wisconsin and is certified by the American Society for Quality as a Reliability Engineer and a Software Quality Engineer. Mr. Fries is a member of the IEEE Software Engineering Subcommittee. He was a member of the AAMI Medical Device Software Committee that developed IEC 62304. He was also a member of the AAMI Technical Committee that developed ISO 13485.
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ISBN 9781439894910, September 2012, 501 pp