Handbook of Medical Device Design

Richard C. Fries is Manager of Reliability Engineering, Datex-Ohmeda, Inc., Madison, Wisconsin.

Section 1: Standards and Regulations 1. FDA Regulations 2. Preparing an FDA Submission 3. European Standards and Regulations 4. The Medical Device Directives 5. The Basis of ISO 9001 6. Design of Medical Devices for the Canadian Market 7. Pacific Rim Standards and Regulations 8. Overview of Software Standards Section 2: Determining and Documenting Requirements 9. Defining the Device 10. Documenting Product Requirements 11. Medical Device Records Section 3: The Design Phase 12. Hazard and Risk Analysis 13. Hardware Design 14. Software Design 15. Human Factors Engineering 16. Biocompatibility 17. Reliability Assurance 18. Product User Guides 19. Translation: "It’s a Small World After All" 20. Liability 21. Intellectual Property Section 4: Verification and Validation 22. Testing 23. Overview of Verification and Validation for Embedded Software in Medical Systems 24. Software Verification and Validation 25. Reliability Evaluation 26. Analysis of Test Results Section 5: The Manufacturing/Field Phase 27. Quality System Regulation and Manufacturing 28. Configuration Management 29. The Quality System Audit 30. Analysis of Field Data