Medical Device Design

Innovation from Concept to Market

Peter J. Ogrodnik

• Publisher: Academic Press
• Year: 2019
• eBook ISBN: 9780128149638
• Edition: 2
• Topic: Technology & Engineering
• Subtopic: Biomedical Science
• Index: Technology & Engineering

Medical Device Design: Innovation from Concept to Market, Second Edition provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace.This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design.- Provides a reference to standards and regulations that have been updated, including ISO 13485: 2016, FDA regulations and the European Medical Device Regulation- Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more- Presents additional content around software and biocompatibility concerns

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright
• Dedication
• Preface
• Acknowledgements
• Chapter 1. Introduction
• Chapter 2. Classifying medical devices
• Chapter 3. The design process
• Chapter 4. Implementing design procedures
• Chapter 5. Developing your product design specification
• Chapter 6. Generating ideas and concepts
• Chapter 7. Enhancing quality in design
• Chapter 8. Design realisation/detailed design
• Chapter 9. Risk management, risk analysis and ISO 14971
• Chapter 10. Evaluation (validation and verification)
• Chapter 11. Manufacturing supply chain
• Chapter 12. Labeling and instructions for use
• Chapter 13. Post market surveillance
• Chapter 14. Protecting your IP
• Chapter 15. Obtaining regulatory approval to market
• Appendix A. Useful websites
• Appendix B
• Appendix C
• Appendix D
• Appendix E
• Appendix F. Further worked examples of a PDS
• Index