Medical Device Design
Innovation from Concept to Market
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Product details:
- Edition number 2
- Publisher Elsevier Science
- Date of Publication 26 October 2019
- ISBN 9780128149621
- Binding Paperback
- No. of pages538 pages
- Size 234x190 mm
- Weight 880 g
- Language English 0
Categories
Long description:
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.
MoreTable of Contents:
1. Introduction2. Classifying Medical Devices3. The Design Process4. Implementing Design Procedures5. Developing Your Product Design Specification6. Generating Ideas and Concepts7. Enhancing Quality in Design8. Design Realisation/Detailed Design9. Risk Management, Risk Analysis and ISO 1497110. Evaluation (Validation and Verification)11. Manufacturing Supply Chain12. Labelling and Instructions for Use13. Post Market Surveillance14. Protecting Your IP15. Obtaining Regulatory Approval to Market
Appendix A. Useful WebsitesAppendix B. TablesAppendix C. ISO 14971 Annex C Pre-Risk Analysis QuestionnaireAppendix D. Generic Codes for Class I Medical Devices (MHRA)Appendix E. Basic Materials Properties for Materials SelectionAppendix F. Standard Materials in Medicak Devices
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