Handbook of Medical Device Design

by Richard C. Fries (Editor)

Overview

First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.

Product Details

ISBN-13:	9780367249519
Publisher:	CRC Press
Publication date:	02/19/2021
Series:	Routledge Revivals
Pages:	792
Sales rank:	740,784
Product dimensions:	6.00(w) x 9.00(h) x (d)

About the Author

Richard C. Fries is Manager of Reliability Engineering, Datex-Ohmeda, Inc., Madison, Wisconsin.

Table of Contents

Section 1: Standards and Regulations 1. FDA Regulations 2. Preparing an FDA Submission 3. European Standards and Regulations 4. The Medical Device Directives 5. The Basis of ISO 9001 6. Design of Medical Devices for the Canadian Market 7. Pacific Rim Standards and Regulations 8. Overview of Software Standards Section 2: Determining and Documenting Requirements 9. Defining the Device 10. Documenting Product Requirements 11. Medical Device Records Section 3: The Design Phase 12. Hazard and Risk Analysis 13. Hardware Design 14. Software Design 15. Human Factors Engineering 16. Biocompatibility 17. Reliability Assurance 18. Product User Guides 19. Translation: "It’s a Small World After All" 20. Liability 21. Intellectual Property Section 4: Verification and Validation 22. Testing 23. Overview of Verification and Validation for Embedded Software in Medical Systems 24. Software Verification and Validation 25. Reliability Evaluation 26. Analysis of Test Results Section 5: The Manufacturing/Field Phase 27. Quality System Regulation and Manufacturing 28. Configuration Management 29. The Quality System Audit 30. Analysis of Field Data

 

Editorial Reviews

"a worthwhile reference and source. . ..Biomedical and engineering libraries would benefit from this addition to their reference collections."
—-E-Streams

From the Publisher

a worthwhile reference and source....Biomedical and engineering libraries would benefit from this addition to their reference collections.

E-Streams

For those working in the development and use of medical devices, presents practical knowledge about biomedical technology and regulations, techniques for improving the methodology of designing and manufacturing medical devices, and ways to improve the functionality and reliability of the devices themselves. Chapters in the first section are devoted to standards and regulations: FDA regulations and submission preparation; European, Canadian, and Pacific Rim standards and regulations; medical device directives; basics of ISO 9001; and software standards. Subsequent sections discuss in detail determining and documenting requirements, the design phase, verification and validation, and the manufacturing/field phase. The editor and the contributors are veteran reliability engineers. Annotation c. Book News, Inc., Portland, OR (booknews.com)

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