Guidelines for Failure Modes and Effects Analysis for Medical Devices
eBook - PDF

Guidelines for Failure Modes and Effects Analysis for Medical Devices

  1. 177 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Guidelines for Failure Modes and Effects Analysis for Medical Devices

About this book

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 dramatically cutting the time required for studies, Guidelines for Failure Modes and Effects Analysis for Medical Devices focuses on Failure Modes and Effects Analysis (FMEA) and its application throughout the life cycle of a medical device. It outlines the major U.S. and E.U. standards and regulations and provides a detailed yet easy-to-read overview of risk management and risk analysis methodologies, common FMEA pitfalls, and FMECA-Failure Mode, Effects, and Criticality Analysis.Discover how the FMEA methodology can help your company achieve a more cost-effective manufacturing process by improving the quality and reliability of your products. This new FMEA manual from the experts at Dyadem is the ultimate resource for you and your colleagues to learn more about Failure Modes and Effects Analysis and then teach others at your facility. This comprehensive manual is sure to become a standard reference for engineering professionals.

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Information

Publisher
CRC Press
Year
2018
Edition
1
eBook ISBN
9780203490112
Topic
Technology & Engineering
Subtopic
Electrical Engineering & Telecommunications
Index
Technology & Engineering

Table of contents

  1. Cover
  2. Title Page
  3. Copyright Page
  4. Table of Contents
  5. Glossary
  6. Chapter 1 Introduction
  7. Chapter 2 Regulations & Standards Governing Medical Device Manufacturing
  8. Chapter 3 Risk Management of Medical Devices
  9. Chapter 4 Risk Analysis Methodologies
  10. Chapter 5 Overview of FMEA
  11. Chapter 6 FMEA Procedures
  12. Chapter 7 FMEA Team
  13. Chapter 8 Pitfalls with FMEA
  14. Chapter 9 Common Tools Used with FMEA
  15. Chapter 10 Product Life Cycle & FMEA
  16. Chapter 11 Product/Design FMEA
  17. Chapter 12 Process FMEA
  18. Chapter 13 Application FMEA
  19. Chapter 14 Service FMEA
  20. Chapter 15 Post FMEA Study
  21. Chapter 16 Control Plans
  22. Chapter 17 Overview of Failure Mode, Effects, and Criticality Analysis (FMECA)
  23. References

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Yes, you can access Guidelines for Failure Modes and Effects Analysis for Medical Devices by Dyadem Press in PDF and/or ePUB format, as well as other popular books in Technology & Engineering & Electrical Engineering & Telecommunications. We have over 1.5 million books available in our catalogue for you to explore.