A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs.
1. Chapter 1. Introduction - p. 1 2. Chapter 2. Planning clinical/performance evaluations - p. 65 3. Chapter 3. Identifying clinical/performance data - p. 127 4. Chapter 4. Appraising clinical/performance data - p. 167 5. Chapter 5. Analyzing clinical/performance data - p. 201 6. Chapter 6. Establishing clinical benefit-risk ratios - p. 235 7. Chapter 7. Writing clinical/performance evaluation documents - p. 247 8. Chapter 8. Writing safety and performance summary documents - p. 287 9. Chapter 9. Reviewing clinical/performance evaluation documents - p. 301 10. Chapter 10. Integrating clinical evaluation, postmarket surveillance and risk management systems - p. 325 11. Chapter 11. Understanding clinical evaluation regulations outside of Europe - p. 355 12. Chapter 12. Forecasting clinical evaluation future directions - p. 387 13. Appendix A. Example regulatory evolution timeline - p. 395 14. Appendix B. MEDDEV guidance list - p. 397 15. Appendix C. Medical Device Coordinating Group endorsed guidance documents - p. 401 16. Appendix D. Appraisal question examples - p. 409 17. Appendix E. Notified Body clinical evaluation checklist - p. 411 18. Appendix F. Clinical evaluation plan/performance evaluation plan requirements checklist - p. 419 19. Appendix G. Clinical evaluation standard operating procedure example 1 (short) - p. 421 20. Appendix H. Clinical evaluation standard operating procedure example 2 (long) - p. 423 21. Appendix I. Clinical evaluation work instruction example - p. 429 22. Appendix J. Kick off meeting agenda/minutes/slides - p. 437 23. Appendix K. Clinical Evaluation Plan Template - p. 439 24. Appendix L. Clinical evaluation report template - p. 451 25. Appendix M. Clinical data requirements checklists - p. 473 26. Appendix N. Declaration of Interest template - p. 477 27. Appendix O. Summary of safety and clinical performance/summary of safety and performance template - p. 480 28. Appendix P. Benefit-risk ratio checklist - p. 483 29. Appendix Q. Clinical evaluation/performance evaluation strategy checklist - p. 485 30. Appendix R. Clinical data requirements matrix - p. 487 31. Appendix S. Reference list of regulatory jurisdictions - p. 489 32. Appendix T. Answers to review questions - p. 491 33. Index - p. 509
A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs.
1. Chapter 1. Introduction - p. 1 2. Chapter 2. Planning clinical/performance evaluations - p. 65 3. Chapter 3. Identifying clinical/performance data - p. 127 4. Chapter 4. Appraising clinical/performance data - p. 167 5. Chapter 5. Analyzing clinical/performance data - p. 201 6. Chapter 6. Establishing clinical benefit-risk ratios - p. 235 7. Chapter 7. Writing clinical/performance evaluation documents - p. 247 8. Chapter 8. Writing safety and performance summary documents - p. 287 9. Chapter 9. Reviewing clinical/performance evaluation documents - p. 301 10. Chapter 10. Integrating clinical evaluation, postmarket surveillance and risk management systems - p. 325 11. Chapter 11. Understanding clinical evaluation regulations outside of Europe - p. 355 12. Chapter 12. Forecasting clinical evaluation future directions - p. 387 13. Appendix A. Example regulatory evolution timeline - p. 395 14. Appendix B. MEDDEV guidance list - p. 397 15. Appendix C. Medical Device Coordinating Group endorsed guidance documents - p. 401 16. Appendix D. Appraisal question examples - p. 409 17. Appendix E. Notified Body clinical evaluation checklist - p. 411 18. Appendix F. Clinical evaluation plan/performance evaluation plan requirements checklist - p. 419 19. Appendix G. Clinical evaluation standard operating procedure example 1 (short) - p. 421 20. Appendix H. Clinical evaluation standard operating procedure example 2 (long) - p. 423 21. Appendix I. Clinical evaluation work instruction example - p. 429 22. Appendix J. Kick off meeting agenda/minutes/slides - p. 437 23. Appendix K. Clinical Evaluation Plan Template - p. 439 24. Appendix L. Clinical evaluation report template - p. 451 25. Appendix M. Clinical data requirements checklists - p. 473 26. Appendix N. Declaration of Interest template - p. 477 27. Appendix O. Summary of safety and clinical performance/summary of safety and performance template - p. 480 28. Appendix P. Benefit-risk ratio checklist - p. 483 29. Appendix Q. Clinical evaluation/performance evaluation strategy checklist - p. 485 30. Appendix R. Clinical data requirements matrix - p. 487 31. Appendix S. Reference list of regulatory jurisdictions - p. 489 32. Appendix T. Answers to review questions - p. 491 33. Index - p. 509
