Guidelines for Failure Modes and Effects Analysis for Medical Devices (Paperback)

~ Dyadem Press (Author) "Medical device manufacturers face tremendous challenges today, including stringent regulations, vigorous competition, consumer advocate groups, product liability lawsuits and their implications..." (more)
Key Phrases: rating guidelines for severity, salable number, item operating time interval, High Likelihood, Low Likelihood, Standards Governing Medical Device Manufacturing (more...)

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Product Description

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.

Product Details

• Paperback: 190 pages
• Publisher: CRC (March 3, 2003)
• Language: English
• ISBN-10: 0849319102
• ISBN-13: 978-0849319105
• Product Dimensions: 11.1 x 8.5 x 0.6 inches
• Shipping Weight: 1.2 pounds (View shipping rates and policies)
• Average Customer Review: 1.0 out of 5 stars  See all reviews (1 customer review)
• Amazon.com Sales Rank: #895,567 in Books (See Bestsellers in Books)

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Customer Reviews

Most Helpful Customer Reviews

17 of 17 people found the following review helpful:

1.0 out of 5 stars Try Another Book!, June 14, 2005

By	Shavings - See all my reviews

This book is extremely basic. The text is double spaced and not very detailed. Sample FMEA forms are blank templates; no filled in examples are provided. In the process mapping chapter, symbols are missing from Table 9-1. A filled in example of a process map is presented with no descriptive text. A functional block diagram is explained in 21 words - absolutely inadequate though the example in Figure 9-2 helps. A reliability block diagram is shown and is described in 22 words - impossible to decipher! Definitely not worth the price, go elsewhere!