Handbook of Medical Device Design

Herausgeber: Fries, Richard C

• Broschiertes Buch

Produktbeschreibung

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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Produktdetails

• Verlag: Taylor & Francis Ltd (Sales)
• Seitenzahl: 774
• Erscheinungstermin: 19. Februar 2021
• Englisch
• Abmessung: 229mm x 152mm x 40mm
• Gewicht: 1043g
• ISBN-13: 9780367249519
• ISBN-10: 0367249510
• Artikelnr.: 69891500

Autorenporträt

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

Inhaltsangabe

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