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