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.