Description
Book SynopsisChallenged 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
Table of ContentsGlossary, 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
