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Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition

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Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition

Citation Information

Safety Evaluation in the Development of Medical Devices and Combination Products, Third Edition

Shayne Cox Gad

Informa Healthcare 2009

Print ISBN: 978-0-8247-0617-3

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http://dx.doi.org/10.1201/9781439809488

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Front Matter

Abstract - Hi-Res PDF (76 KB) - PDF w/links (77 KB)
Chapter 1. Introduction

Abstract - Hi-Res PDF (80 KB) - PDF w/links (80 KB)
Chapter 2. Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation

Abstract - Hi-Res PDF (1002 KB) - PDF w/links (821 KB)
Chapter 3. Road Map to Test Selections

Abstract - Hi-Res PDF (441 KB) - PDF w/links (435 KB)
Chapter 4. What to Test Sampling and Sample Preparation

Abstract - Hi-Res PDF (91 KB) - PDF w/links (92 KB)
Chapter 5. Cytotoxicity Testing

Abstract - Hi-Res PDF (84 KB) - PDF w/links (88 KB)
Chapter 6. Blood Compatibility

Abstract - Hi-Res PDF (142 KB) - PDF w/links (156 KB)
Chapter 7. Irritation and Pyrogenicity

Abstract - Hi-Res PDF (192 KB) - PDF w/links (199 KB)
Chapter 8. Immunotoxicology

Abstract - Hi-Res PDF (688 KB) - PDF w/links (639 KB)
Chapter 9. Implantation Biology and Studies

Abstract - Hi-Res PDF (134 KB) - PDF w/links (136 KB)
Chapter 10. Genotoxicity

Abstract - Hi-Res PDF (354 KB) - PDF w/links (366 KB)
Chapter 11. Subchronic and Chronic Toxicity and Reproductive and Developmental Toxicity

Abstract - Hi-Res PDF (185 KB) - PDF w/links (198 KB)
Chapter 12. Carcinogenicity

Abstract - Hi-Res PDF (91 KB) - PDF w/links (96 KB)
Chapter 13. Sterility, Sterilization, and Heavy Metals

Abstract - Hi-Res PDF (97 KB) - PDF w/links (98 KB)
Chapter 14. Combination Devices

Abstract - Hi-Res PDF (94 KB) - PDF w/links (96 KB)
Chapter 15. Clinical Studies for Medical Devices

Abstract - Hi-Res PDF (147 KB) - PDF w/links (148 KB)
Chapter 16. Special Studies

Abstract - Hi-Res PDF (185 KB) - PDF w/links (198 KB)
Chapter 17. Case Histories and Problem Resolution

Abstract - Hi-Res PDF (155 KB) - PDF w/links (159 KB)
Appendix A. Non-U.S. Medical Device Regulators

Abstract - Hi-Res PDF (59 KB) - PDF w/links (59 KB)

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