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Medical Device Design
Innovation from Concept to Market
This new edition on medical device design reflects updates to FDA and EU regulations and standards and incorporates new topics and case studies
Peter J. Ogrodnik (Author)
9780128149621, Elsevier Science
Paperback, published 26 October 2019
538 pages
23.4 x 19 x 3.3 cm, 0.88 kg
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.
1. Introduction 2. Classifying Medical Devices 3. The Design Process 4. Implementing Design Procedures 5. Developing Your Product Design Specification 6. Generating Ideas and Concepts 7. Enhancing Quality in Design 8. Design Realisation/Detailed Design 9. Risk Management, Risk Analysis and ISO 14971 10. Evaluation (Validation and Verification) 11. Manufacturing Supply Chain 12. Labelling and Instructions for Use 13. Post Market Surveillance 14. Protecting Your IP 15. Obtaining Regulatory Approval to Market Appendix A. Useful Websites Appendix B. Tables Appendix C. ISO 14971 Annex C Pre–Risk Analysis Questionnaire Appendix D. Generic Codes for Class I Medical Devices (MHRA) Appendix E. Basic Materials Properties for Materials Selection Appendix F. Standard Materials in Medicak Devices
Subject Areas: Biomedical engineering [MQW]
