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Handbook of Medical Device Design de Richard C. Fries

Handbook of Medical Device Design: Routledge Revivals

Editat de Richard C. Fries
en Limba Engleză Hardback – 7 mai 2019
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.
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Specificații

ISBN-13: 9780367249403
ISBN-10: 0367249405
Pagini: 792
Dimensiuni: 152 x 229 mm
Greutate: 0.45 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
Seria Routledge Revivals

Public țintă

Professional

Cuprins

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
 

Notă biografică

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

Recenzii

"a worthwhile reference and source. . ..Biomedical and engineering libraries would benefit from this addition to their reference collections."
---E-Streams

Descriere

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.