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.
1. Chapter 1. Introduction - p. 1 2. Chapter 2. Classifying medical devices - p. 19 3. Chapter 3. The design process - p. 49 4. Chapter 4. Implementing design procedures - p. 77 5. Chapter 5. Developing your (product) design specification - (X)DS - p. 101 6. Chapter 6. Generating ideas and concepts - p. 145 7. Chapter 7. Enhancing quality in design - p. 183 8. Chapter 8. Design realization/detailed design - p. 229 9. Chapter 9. Risk management, risk analysis and ISO 14971 - p. 309 10. Chapter 10. Evaluation (validation and verification) - p. 339 11. Chapter 11. Manufacturing supply chain - p. 405 12. Chapter 12. Labeling and instructions for use - p. 421 13. Chapter 13. Postmarket surveillance - p. 447 14. Chapter 14. Active medical devices and IVDs - p. 463 15. Chapter 15. Software, AI, and medical devices - p. 479 16. Chapter 16. Sustainable healthcare - p. 501 17. Chapter 17. Protecting your IP - p. 511 18. Chapter 18. Obtaining regulatory approval to market - p. 521 19. Appendix A. Useful Websites - p. 543 20. Appendix B. Appendix - p. 553 21. Appendix C. Appendix - p. 557 22. Appendix D. Appendix - p. 567 23. Appendix E. Appendix - p. 573 24. Appendix F. Further worked examples of a PDS∗ - p. 577 25. Index - p. 589
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.
1. Chapter 1. Introduction - p. 1 2. Chapter 2. Classifying medical devices - p. 19 3. Chapter 3. The design process - p. 49 4. Chapter 4. Implementing design procedures - p. 77 5. Chapter 5. Developing your (product) design specification - (X)DS - p. 101 6. Chapter 6. Generating ideas and concepts - p. 145 7. Chapter 7. Enhancing quality in design - p. 183 8. Chapter 8. Design realization/detailed design - p. 229 9. Chapter 9. Risk management, risk analysis and ISO 14971 - p. 309 10. Chapter 10. Evaluation (validation and verification) - p. 339 11. Chapter 11. Manufacturing supply chain - p. 405 12. Chapter 12. Labeling and instructions for use - p. 421 13. Chapter 13. Postmarket surveillance - p. 447 14. Chapter 14. Active medical devices and IVDs - p. 463 15. Chapter 15. Software, AI, and medical devices - p. 479 16. Chapter 16. Sustainable healthcare - p. 501 17. Chapter 17. Protecting your IP - p. 511 18. Chapter 18. Obtaining regulatory approval to market - p. 521 19. Appendix A. Useful Websites - p. 543 20. Appendix B. Appendix - p. 553 21. Appendix C. Appendix - p. 557 22. Appendix D. Appendix - p. 567 23. Appendix E. Appendix - p. 573 24. Appendix F. Further worked examples of a PDS∗ - p. 577 25. Index - p. 589
