This book 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. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly.
1. Chapter 1. Introduction 2. Chapter 2. Classifying Medical Devices 3. Chapter 3. The Design Process 4. Chapter 4. Implementing Design Procedures 5. Chapter 5. Developing Your Product Design Specification 6. Chapter 6. Generating Ideas and Concepts 7. Chapter 7. Quality in Design 8. Chapter 8. Design Realization/Detailed Design 9. Chapter 9. Evaluation (Validation and Verification) 10. Chapter 10. Manufacturing Supply Chain 11. Chapter 11. Labeling and Instructions for Use 12. Chapter 12. Postmarket Surveillance 13. Chapter 13. Protecting Your IP 14. Chapter 14. Obtaining Regulatory Approval to Market 15. Appendix A. Useful Websites 16. Appendix B. Tables 17. Appendix C. ISO 14971 Annex C Pre–Risk Analysis Questionnaire 18. Appendix D. Generic Codes for Class I Medical Devices (MHRA) 19. Appendix E. Basic Materials Properties for Materials Selection 20. Index
This book 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. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly.
1. Chapter 1. Introduction 2. Chapter 2. Classifying Medical Devices 3. Chapter 3. The Design Process 4. Chapter 4. Implementing Design Procedures 5. Chapter 5. Developing Your Product Design Specification 6. Chapter 6. Generating Ideas and Concepts 7. Chapter 7. Quality in Design 8. Chapter 8. Design Realization/Detailed Design 9. Chapter 9. Evaluation (Validation and Verification) 10. Chapter 10. Manufacturing Supply Chain 11. Chapter 11. Labeling and Instructions for Use 12. Chapter 12. Postmarket Surveillance 13. Chapter 13. Protecting Your IP 14. Chapter 14. Obtaining Regulatory Approval to Market 15. Appendix A. Useful Websites 16. Appendix B. Tables 17. Appendix C. ISO 14971 Annex C Pre–Risk Analysis Questionnaire 18. Appendix D. Generic Codes for Class I Medical Devices (MHRA) 19. Appendix E. Basic Materials Properties for Materials Selection 20. Index
