Research Catalog
Handbook of medical device design
- Title
- Handbook of medical device design / edited by Richard C. Fries.
- Publication
- New York : M. Dekker, [2001], ©2001.
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1 Item
| Status | Format | Access | Call Number | Item Location |
|---|---|---|---|---|
| Text | Request in advance | R856.6 .F7482 2001 | Off-site |
Holdings
Details
- Additional Authors
- Fries, Richard C.
- Description
- xviii, 774 pages : illustrations; 24 cm
- Subjects
- Genre/Form
- Handbook.
- Bibliography (note)
- Includes bibliographical references and index.
- Contents
- Sect. 1. Standards and Regulations. Ch. 1. FDA Regulations / Richard C. Fries. Ch. 2. Preparing an FDA Submission / Richard C. Fries. Ch. 3. European Standards and Regulations / Richard C. Fries. Ch. 4. The Medical Device Directives / Richard C. Fries. Ch. 5. The Basics of ISO 9001 / Tina Juneau. Ch. 6. Design of Medical Devices for the Canadian Market / Paul Fabry. Ch. 7. Pacific Rim Standards and Regulations / Richard C. Fries. Ch. 8. Overview of Software Standards / Nancy George -- Sect. 2. Determining and Documenting Requirements. Ch. 9. Defining the Device / Richard C. Fries. Ch. 10. Documenting Product Requirements / Richard C. Fries. Ch. 11. Medical Device Records / Richard C. Fries -- Sect. 3. The Design Phase. Ch. 12. Hazard and Risk Analysis / Markus Weber. Ch. 13. Hardware Design / Richard C. Fries. Ch. 14. Software Design / Sherman Eagles. Ch. 15. Human Factors Engineering / Richard C. Fries. Ch. 16. Biocompatibility / Richard C. Fries.
- Ch. 17. Reliability Assurance / Richard C. Fries. Ch. 18. Product User Guides / Margaret Rickard. Ch. 19. Translation: "It's A Small World After All" / Margaret Richard. Ch. 20. Liability / Richard C. Fries. Ch. 21. Intellectual Property / Richard C. Fries -- Sect. 4. Verification and Validation. Ch. 22. Testing / Lisa Henn. Ch. 23. Overview of Verification and Validation for Embedded Software in Medical Systems / Andre Bloesch. Ch. 24. Software Verification and Validation / Sherman Eagles. Ch. 25. Reliability Evaluation / Richard C. Fries. Ch. 26. Analysis of Test Results / Richard C. Fries -- Sect. 5. The Manufacturing/Field Phase. Ch. 27. Quality System Regulations and Manufacturing / Richard C. Fries. Ch. 28. Configuration Management / Richard C. Fries. Ch. 29. The Quality System Audit / Tina Juneau. Ch. 30. Analysis of Field Data / Richard C. Fries -- App. 1. Chi Square Table -- App. 2. Percent Rank Tables.
- ISBN
- 0824703995 (alk. paper)
- LCCN
- 00059022
- OCLC
- ocm44678479
- SCSB-4111115
- Owning Institutions
- Columbia University Libraries