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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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Teleflex Turned Around Arrow’s Quality System Following FDA Corporate Warning Letter

When an FDA corporate warning letter was sent to Arrow International in 2007 outlining numerous quality system deficiencies, the new owner of the troubled device company knew that drastic steps had to be taken. “This is a story about what can happen to a company, the compliance issues it can become involved in, and more importantly, the steps we took to remediate all of those issues and bring the company back into a healthy compliance mode,” said Michael Crader, VP of global RA/QA at Teleflex. Work to fix Arrow’s quality system began with an analysis of the firm’s data and a shutdown of Arrow plants across the globe. Quality system teams were formed to tackle five key areas: management control, CAPA, production and process control, materials and change management, and design control.

Recent eMDR Change By FDA Asks Adverse Event Reporters About Third-Party Servicers

The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.

Q3 Recalls Snapshot: It’s Good News For Industry And Patients As Recall Events, Recalled Units Fall

Medical device manufacturers initiated fewer recalls in the third quarter of 2020. Check out our Q3 recalls infographic.


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