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Mar 8, 2016

The #1 Cause of Medical Device Recalls—and How to Avoid It

FDA report lists faulty software 
design as top recall cause.


by Lisa Weeks,MasterControl Communications


Would it surprise you to learn that the most common cause of medical device recall, according to the FDA, is software design failure? It shouldn’t. These days, it’s hard to find a device that doesn’t rely on the use of sophisticated software to operate. What’s more, a defective software component is often harder to detect than, let’s say, a defective electrical component. It really is the perfect recipe for design disaster, but it doesn’t have to be—if you know how to use risk.

This article, originally posted by Qmed, examines the unique challenges of identifying defective software, and how you can minimize those challenges using effective risk management. Are you designing for medical device success—or recall? Read the full article to find out!


This article is related to the White Paper: Software Trends in the Medical Device IndustryTo get the full details, please download your free copy.


Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences and other regulated environments. She is a staff writer at GxP Lifeline and a contributor to many leading life science publications, including Medical Product Manufacturing News (MPMN) and CERM Risk Insights.





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