Reliable Design of Medical Devices

ISBN-13: 9781439894910 / Angielski / Twarda / 2012 / 501 str.

Richard C. Fries

Opis

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.

Spis treści

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.

O autorze

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.