Full Description
Medical Device Design: Innovation from Concept to Market, Third Edition provides the bridge between engineering design and medical device development. The book clearly explains the process of medical device development - from very early stages of conceptualization to commercialization on the global market. 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, enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace.
This book is suitable for professional engineers, both new and experienced, as well as students taking a course in medical device design.
Contents
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. Quality in Design
8. Design Realization/Detailed Design
9. Evaluation Chapter 10. Manufacturing Supply Chain
11. Labelling and Instructions for Use
12. Postmarket Surveillance Chapter 13 Sustainability and Resilient systems
14. Protecting Your IP
15. Exploiting IP
16. Obtaining Regulatory Approval to Market
16. Active medical devices
17. Software in Medical Devices
18 AI in Medical Devices
Appendix
A. Useful Websites FDA Medical Devices
B. Tables
C. ISO 14971 Annex C Pre-Risk Analysis Questionnaire Appendix
D. Generic Codes for Class I Medical Devices (MHRA)FDA Class I and II Exempt Devices
E. Basic Materials Properties for Materials Selection E.1 Density E.2 Stress and Strain
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