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Quality system survey

This article was originally published in The Gray Sheet

Executive Summary

Many device firms' quality management systems fail to adequately address safety issues associated with increasingly complex global supply chains, according to a survey of device industry professionals presented at the AdvaMed 2009 conference Oct. 12-14 in Washington, D.C. The study, conducted by quality management and compliance solutions provider Sparta Systems, found that 45% of firms feel their current quality systems are insufficient to mitigate compliance, risk and safety issues associated with supply chain management. In addition, 60% of companies have not begun preparing for FDA's electronic Medical Device Reporting mandate, proposed in August, which would require e-submission of post-market adverse events

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