ABSTRACT

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.

chapter 1|2 pages

Introduction

chapter 3|4 pages

Risk Management of Medical Devices

chapter 4|3 pages

Risk Analysis Methodologies

chapter 5|3 pages

Overview of FMEA

chapter 6|9 pages

FMEA Procedures

chapter 7|1 pages

FMEA Team

chapter 8|2 pages

Pitfalls with FMEA

chapter 9|4 pages

Common Tools Used with FMEA

chapter 10|5 pages

Product Life Cycle & FMEA

chapter 11|5 pages

Product/Design FMEA

chapter 12|6 pages

Process FMEA

chapter 13|5 pages

Application FMEA

chapter 14|6 pages

Service FMEA

chapter 15|1 pages

Post FMEA Study

chapter 16|4 pages

Control Plans