Medical Device Design: Innovation from Concept to Market (Paperback, 2)

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. Risk management, risk analysis and ISO 14971 10. Evaluation (Validation and Verification) 11. Manufacturing Supply Chain 12. Labelling and Instructions for Use 13. Postmarket Surveillance 14. Protecting Your IP 15. Obtaining Regulatory Approval to Market

Appendix A. Useful Websites FDA Medical Devices Appendix B. Tables Appendix 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 Appendix E. Basic Materials Properties for Materials Selection E.1 Density E.2 Stress and Strain Appendix F.Standard Materials in Medicak Devices