Reliable Design of Medical Devices

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.

"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

• 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.