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http://dx.doi.org/10.1201/9780203490112
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Front MatterAbstract - Hi-Res PDF (958 KB) - PDF w/links (753 KB)
Chapter 1. IntroductionAbstract - Hi-Res PDF (477 KB) - PDF w/links (408 KB)
Chapter 2. Regulations & StandardsGoverning MedicalDevice ManufacturingAbstract - Hi-Res PDF (1079 KB) - PDF w/links (827 KB)
Chapter 3. Risk Management ofMedical DevicesAbstract - Hi-Res PDF (692 KB) - PDF w/links (558 KB)
Chapter 4. Risk AnalysisMethodologiesAbstract - Hi-Res PDF (419 KB) - PDF w/links (370 KB)
Chapter 5. Overview of FMEAAbstract - Hi-Res PDF (659 KB) - PDF w/links (535 KB)
Chapter 6. FMEA ProceduresAbstract - Hi-Res PDF (1161 KB) - PDF w/links (909 KB)
Chapter 7. FMEA TeamAbstract - Hi-Res PDF (308 KB) - PDF w/links (289 KB)
Chapter 8. Pitfalls with FMEAAbstract - Hi-Res PDF (319 KB) - PDF w/links (299 KB)
Chapter 9. Common Tools Usedwith FMEAAbstract - Hi-Res PDF (538 KB) - PDF w/links (456 KB)
Chapter 10. Product Life Cycle &FMEAAbstract - Hi-Res PDF (905 KB) - PDF w/links (714 KB)
Chapter 11. Product/Design FMEAAbstract - Hi-Res PDF (883 KB) - PDF w/links (694 KB)
Chapter 12. Process FMEAAbstract - Hi-Res PDF (929 KB) - PDF w/links (721 KB)
Chapter 13. Application FMEAAbstract - Hi-Res PDF (883 KB) - PDF w/links (695 KB)
Chapter 14. Service FMEAAbstract - Hi-Res PDF (935 KB) - PDF w/links (731 KB)
Chapter 15. Post FMEA StudyAbstract - Hi-Res PDF (321 KB) - PDF w/links (298 KB)
Chapter 16. Control PlansAbstract - Hi-Res PDF (699 KB) - PDF w/links (560 KB)
Chapter 17. Overview of FailureMode, Effects andCriticality Analysis(FMECA)Abstract - Hi-Res PDF (806 KB) - PDF w/links (640 KB)
ReferencesAbstract - Hi-Res PDF (513 KB) - PDF w/links (435 KB)
