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Sparta Systems, Inc.

Sparta Systems(TM) Outlines Tips and Tactics to Prepare for eMDR Mandate

Published in Medical Letter on the CDC and FDA, July 5th, 2009

Sparta Systems, Inc., the maker of TrackWise(R) software and the market leader in enterprise quality and compliance management solutions, today outlined its recommendations to help companies prepare for electronic Medical Device Reporting (eMDR), the expected regulation from FDA Center for Devices and Radiological Health (CDRH). The mandate will require electronic filing of safety reports for medical device organizations.

Understanding the daunting challenges presented to medical device companies in transitioning to an electronic submission system, Sparta Systems has developed a multi-step approach that organizations can employ to prepare for the eMDR legislation in...

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