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Boston Scientific Uses Risk-Based Process To Swiftly Identify, Correct Problem Devices

This article was originally published in The Gray Sheet

Executive Summary

The manufacturer's path to a company-wide risk management program was a tough row to hoe after it was issued an FDA corporate warning letter in 2006. But now its quality system is back on track and the firm is finding it easier than ever to deal with nonconforming product by using a risk-based process that involves layers of professional review, the firm's VP of global quality systems says.

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