Table of Contents

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

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.

Reviews

"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