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. 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.
Guidelines for Failure Modes and Effects Analysis for Medical Devices is written as a practical guide to achieving corporate consistency while dramatically cutting the time required for studies. It will help you prevent patient injuries, costly product recalls, and production department down-time. 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.
By:
Dyadem Press
Imprint: CRC Press Inc
Country of Publication: United States
Dimensions:
Height: 285mm,
Width: 222mm,
Spine: 19mm
Weight: 350g
ISBN: 9780849319105
ISBN 10: 0849319102
Pages: 190
Publication Date: 03 March 2003
Audience:
General/trade
,
Professional and scholarly
,
College/higher education
,
ELT Advanced
,
Undergraduate
Format: Paperback
Publisher's Status: Active
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
