First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.
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: "Its 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
Richard C. Fries is Manager of Reliability Engineering, Datex-Ohmeda, Inc., Madison, Wisconsin.
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