Medical device design :
Ogrodnik, Peter J.
Medical device design : innovation from concept to market / Peter J. Ogrodnik - 1st ed. - Amsterdam ; Boston : Elsevier/Academic Press, 2013 - xvii, 350 p. : ill. ; 25 cm.
Inclou referències bibliogràfiques i índex.
Dedication -- Preface -- Acknowledgements -- Chapter 1. Introduction -- 1.1 What Is Design? -- 1.2 The Design Life Cycle -- 1.3 Medical Devices Definitions -- 1.4 Summary -- References -- Chapter 2. Classifying Medical Devices -- 2.1 Introduction: Why Classify? -- 2.2 Classification Rules -- 2.3 Classification Case Study -- 2.4 Classification Models -- 2.5 Classification and the Design Process -- 2.6 Summary -- References -- Chapter 3. The Design Process -- 3.1 Design Process versus Design Control -- 3.2 Design Models -- 3.3 Managing Design -- 3.4 Cross-Reference with Regulatory Requirements -- 3.5 Summary --Tasks -- References -- Further Reading -- Chapter 4. Implementing Design Procedures -- 4.1 Introduction -- 4.2 Review of Guidelines -- 4.3 Overall Procedure -- 4.4 Audit /Review Procedure -- 4.5 The Design Process -- 4.6 Implementing a Procedure -- 4.7 Summary -- References -- Chapter 5. Developing Your Product Design Specification -- 5.1 Introduction -- 5.2 Developing the Statement of Need (or Brief) -- 5.3 The Product Design Specification (PDS) -- 5.4 Finding, Extracting, and Analyzing the Content -- References -- Chapter 6. Generating Ideas and Concepts -- 6.1 Introduction -- 6.2 The “Engineer’s Notebook” -- 6.3 Creative Space -- 6.4 Generating Concepts/Ideas -- 6.5 Selecting Concepts and Ideas -- 6.6 Summary -- References -- Chapter 7. Quality in Design -- 7.1 Introduction -- 7.2 Optimization -- 7.3 Design of Experiments/2k Factorial Experiments -- 7.4 House of Quality -- 7.5 Failure Mode and Effect Analysis (FMEA) -- 7.6 D4X -- 7.7 Six Sigma -- 7.8 Summary -- References -- Chapter 8. Design Realization/Detailed Design -- 8.1 Introduction -- 8.2 The Process to Design Realization -- 8.3 Assemble Your Detailed Design Team -- 8.4 Design Calculations -- 8.5 Materials Selection -- 8.6 Computer-Aided Design -- 8.7 D4X -- 8.8 Design for Usability (DFU) -- 8.9 Summary -- References -- Chapter 9. Evaluation (Validation and Verification) -- 9.1 Introduction -- 9.2 Risk Analysis -- 9.3 Criteria-Based Evaluation -- 9.4 Computer-Based Evaluation -- 9.5 Value to “Healthcare” Analysis -- 9.6 Clinical Studies and Clinical Trials -- 9.7 Literature Review -- 9.8 Format for Formal Clinical Evaluation Report -- 9.9 Summary -- References -- Chapter 10. Manufacturing Supply Chain -- 10.1 Introduction -- 10.2 Identifying Potential Suppliers -- 10.3 Packaging -- 10.4 Procurement -- 10.5 Summary -- Further Reading -- Chapter 11. Labeling and Instructions for Use -- 11.1 Introduction -- 11.2 Standard Symbols and Texts -- 11.3 Labeling -- 11.4 Marking -- 11.5 IFUs and Surgical Techniques -- 11.6 Surgical Technique -- 11.7 Declarations -- 11.8 Translation -- 11.9 Summary -- References -- Chapter 12. Postmarket Surveillance -- 12.1 Introduction -- 12.2 PMS and Its Role in Design -- 12.3 Tools -- 12.4 Using Your Existing Contacts -- 12.5 Vigilance -- 12.6 The Good, the Bad, and the Ugly -- 12.7 Summary -- References -- Further Reading -- Chapter 13. Protecting Your IP -- 13.1 Introduction -- 13.2 Types of IP Protection -- 13.3 Keeping Mum -- 13.4 Talking with Partners -- 13.5 Summary -- References -- Chapter 14. Obtaining Regulatory Approval to Market -- 14.1 Introduction -- 14.2 Class I Devices -- 14.3 Higher Classifications -- 14.4 FDA Process -- 14.5 EC Process -- 14.6 Getting to Market -- 14.7 Summary -- References -- 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 -- Index
9780123919427 0123919428
2012540007
016206281 Uk
Medicina--Aparells i instruments--Disseny i construcció
Medicina--Aparells i instruments--Normes
Medicina--Aparells i instruments--Avaluació
Enginyeria--Disseny
R856 / .O37 2013
610.28/4
Medical device design : innovation from concept to market / Peter J. Ogrodnik - 1st ed. - Amsterdam ; Boston : Elsevier/Academic Press, 2013 - xvii, 350 p. : ill. ; 25 cm.
Inclou referències bibliogràfiques i índex.
Dedication -- Preface -- Acknowledgements -- Chapter 1. Introduction -- 1.1 What Is Design? -- 1.2 The Design Life Cycle -- 1.3 Medical Devices Definitions -- 1.4 Summary -- References -- Chapter 2. Classifying Medical Devices -- 2.1 Introduction: Why Classify? -- 2.2 Classification Rules -- 2.3 Classification Case Study -- 2.4 Classification Models -- 2.5 Classification and the Design Process -- 2.6 Summary -- References -- Chapter 3. The Design Process -- 3.1 Design Process versus Design Control -- 3.2 Design Models -- 3.3 Managing Design -- 3.4 Cross-Reference with Regulatory Requirements -- 3.5 Summary --Tasks -- References -- Further Reading -- Chapter 4. Implementing Design Procedures -- 4.1 Introduction -- 4.2 Review of Guidelines -- 4.3 Overall Procedure -- 4.4 Audit /Review Procedure -- 4.5 The Design Process -- 4.6 Implementing a Procedure -- 4.7 Summary -- References -- Chapter 5. Developing Your Product Design Specification -- 5.1 Introduction -- 5.2 Developing the Statement of Need (or Brief) -- 5.3 The Product Design Specification (PDS) -- 5.4 Finding, Extracting, and Analyzing the Content -- References -- Chapter 6. Generating Ideas and Concepts -- 6.1 Introduction -- 6.2 The “Engineer’s Notebook” -- 6.3 Creative Space -- 6.4 Generating Concepts/Ideas -- 6.5 Selecting Concepts and Ideas -- 6.6 Summary -- References -- Chapter 7. Quality in Design -- 7.1 Introduction -- 7.2 Optimization -- 7.3 Design of Experiments/2k Factorial Experiments -- 7.4 House of Quality -- 7.5 Failure Mode and Effect Analysis (FMEA) -- 7.6 D4X -- 7.7 Six Sigma -- 7.8 Summary -- References -- Chapter 8. Design Realization/Detailed Design -- 8.1 Introduction -- 8.2 The Process to Design Realization -- 8.3 Assemble Your Detailed Design Team -- 8.4 Design Calculations -- 8.5 Materials Selection -- 8.6 Computer-Aided Design -- 8.7 D4X -- 8.8 Design for Usability (DFU) -- 8.9 Summary -- References -- Chapter 9. Evaluation (Validation and Verification) -- 9.1 Introduction -- 9.2 Risk Analysis -- 9.3 Criteria-Based Evaluation -- 9.4 Computer-Based Evaluation -- 9.5 Value to “Healthcare” Analysis -- 9.6 Clinical Studies and Clinical Trials -- 9.7 Literature Review -- 9.8 Format for Formal Clinical Evaluation Report -- 9.9 Summary -- References -- Chapter 10. Manufacturing Supply Chain -- 10.1 Introduction -- 10.2 Identifying Potential Suppliers -- 10.3 Packaging -- 10.4 Procurement -- 10.5 Summary -- Further Reading -- Chapter 11. Labeling and Instructions for Use -- 11.1 Introduction -- 11.2 Standard Symbols and Texts -- 11.3 Labeling -- 11.4 Marking -- 11.5 IFUs and Surgical Techniques -- 11.6 Surgical Technique -- 11.7 Declarations -- 11.8 Translation -- 11.9 Summary -- References -- Chapter 12. Postmarket Surveillance -- 12.1 Introduction -- 12.2 PMS and Its Role in Design -- 12.3 Tools -- 12.4 Using Your Existing Contacts -- 12.5 Vigilance -- 12.6 The Good, the Bad, and the Ugly -- 12.7 Summary -- References -- Further Reading -- Chapter 13. Protecting Your IP -- 13.1 Introduction -- 13.2 Types of IP Protection -- 13.3 Keeping Mum -- 13.4 Talking with Partners -- 13.5 Summary -- References -- Chapter 14. Obtaining Regulatory Approval to Market -- 14.1 Introduction -- 14.2 Class I Devices -- 14.3 Higher Classifications -- 14.4 FDA Process -- 14.5 EC Process -- 14.6 Getting to Market -- 14.7 Summary -- References -- 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 -- Index
9780123919427 0123919428
2012540007
016206281 Uk
Medicina--Aparells i instruments--Disseny i construcció
Medicina--Aparells i instruments--Normes
Medicina--Aparells i instruments--Avaluació
Enginyeria--Disseny
R856 / .O37 2013
610.28/4