Guidelines For Failure Modes And Effects Analysis

Informationen zum Autor Dyadem Press Klappentext 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 that goal. These guidelines focus 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. Zusammenfassung Presents guidelines that focus on failure modes and effects analysis (FMEA) and its application throughout the life cycle of a medical device. This book outlines the major US and EU standards and regulations. It presents an overview of risk management and risk analysis methodologies, and common FMEA pitfalls. Inhaltsverzeichnis Glossary, 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 Study, CHAPTER 16 - Control Plans, CHAPTER 17 - Overview of Failure Mode, Effects, and Criticality Analysis (FMECA), References

Product details

• Authors: Press Daydem, Dyadem Press, Dyadem Press, Dyadem (Richmond Hill Press, Press Dyadem
• Publisher: CRC Press
• Languages: English
• Product format: Paperback / Softback
• Released: 03.03.2003
• EAN: 9780849319105
• ISBN: 978-0-8493-1910-5
• Dimensions: 217 mm x 280 mm x 12 mm
• Subjects: Natural sciences, medicine, IT, technology > Medicine; BUSINESS & ECONOMICS / Decision-Making & Problem Solving, TECHNOLOGY & ENGINEERING / Industrial Engineering, TECHNOLOGY & ENGINEERING / Manufacturing, BUSINESS & ECONOMICS / Industries / Manufacturing, MEDICAL / Instruments & Supplies, Management decision making, Medical equipment & techniques, Manufacturing industries, Hi-Tech Manufacturing Industries, Precision engineering and manufacturing, Precision instruments manufacture, Medical equipment and techniques