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ISBN 10: 0429180004
ISBN 13: 9780429180002
Author: Richard C. Fries
The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and qua
Section 1: Standards and Regulations
2. Preparing an FDA Submission
3. European Standards and Regulations
4. The Medical Device Directives
5. The Basics 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 Regulations and Manufacturing
28. Configuration Management
29. The Quality System Audit
30. Analysis of Field Data
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Tags: Richard Fries, Handbook, Medical, Device
