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