Reliable Design of Medical Devices

Richard C. Fries (ISORel, Inc., Fitchburg, Wisconsin, USA)

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English

CRC Press
31 March 2017

Regulation of medicines & medical devices; Biomedical engineering; Life sciences: general issues; Biotechnology; Environmental science, engineering & technology

As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. 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 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.

By: Richard C. Fries (ISORel Inc. Fitchburg Wisconsin USA)
Imprint: CRC Press
Country of Publication: United Kingdom
Edition: 3rd edition
Dimensions: Height: 234mm, Width: 156mm,
Weight: 612g
ISBN: 9781138075191
ISBN 10: 1138075191
Pages: 504
Publication Date: 31 March 2017
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

The Basics of Reliability: Reliability. The Concept of Failure. The Product Design and Development Process. The Concept Phase: Defining the Device. Safety and Risk Management. Documents and Deliverables. The Feasibility Phase: The FDA. The Medical Devices Directives. Important Medical Device Standards. Human Factors. Requirements Engineering. Liability. Intellectual Property. The Project Team. The Reliability Goal and Plan. Documents and Deliverables. The Design Phase: Hardware Design. Hardware Risk Analysis. Design and Project Metrics. Design for Six Sigma. Software Design. Software Coding. Software Risk Analysis. Software Metrics. Documents and Deliverables. Verification and Validation: The Basis and Types of Testing. Hardware Verification and Validation. Hardware Data Analysis. Software Verification and Validation. Software Data Analysis. Documents and Deliverables. Design Transfer and Manufacturing: Transfer to Manufacturing. Hardware Manufacturing. Software Manufacturing. Configuration Management. Documents and Deliverables. Field Activity: Analysis of Field Data. Monitored Activity. Appendices. Index.

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.

Reviews for 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] who wish to develop a product. -Jon Sensinger, Rehabilitation Institute of Chicago, Illinois, USA ... my interest is piqued. I think it can be a very interesting and useful resource for engineers and other stakeholders involved in the medical device design and production process. -Carl Nelson, University of Nebraska-Lincoln, USA Don't let the name fool you- this book is about much more than reliability engineering. While this book opens with a discussion of reliability and failure, it quickly transitions to discussing the entire product development process, from concept through verification, and even includes design transfer and post-market field actions. ...There is a lot of wisdom in this book. You can tell that the author has seen a lot of projects and wants the reader to avoid the mistakes that he has encountered. --Reading Room, Biomedical Instrumentation and Technology, September/October 2013