Guidelines for failure modes and effects analysis for medical devices
Challenged by stringent regulations, vigorous competition, and liability lawsuits, medical device manufactures must develop safe, reliable, and cost-effective products, and managing and reducing risk is a vital element of reaching that goal. A practical guide to achieving corporate consistency while...
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| Format: | eBook |
| Language: | English |
| Language Notes: | English. |
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[Place of publication not identified]
CRC Press,
2018.
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| Series: | FMEA for medical devices
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| Subjects: | |
| Online Access: | Connect to the full text of this electronic book |
Table of Contents:
- Book Cover; Title; Copyright; About Dyadem Engineering Corporation; Table of Contents; CHAPTER 1 Introduction; CHAPTER 2 Regulations & Standards Governing Medical Device Manufacturing; CHAPTER 3 Risk Management of Medical Devices; CHAPTER 4 Risk Analysis Methodologies; CHAPTER 5 Overview of FMEA; CHAPTER 6 FMEA Procedures; CHAPTER 7 FMEA Team; CHAPTER 8 Pitfalls with FMEA; CHAPTER 9 Common Tools Used with FMEA; CHAPTER 10 Product Life Cycle & FMEA; CHAPTER 11 Product/Design FMEA; CHAPTER 12 Process FMEA; CHAPTER 13 Application FMEA; CHAPTER 14 Service FMEA
- CHAPTER 15 Post FMEA StudyCHAPTER 16 Control Plans; CHAPTER 17 Overview of Failure Mode, Effects and Criticality Analysis (FMECA); References