(Sparta Systems: Holmdel, NJ) -- Sparta Systems Inc., the maker of TrackWise software and the market leader in enterprise quality and compliance management solutions, has 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 advance.  These strategies will arm organizations for compliance with the legislation when eMDR reporting is mandated, with tactics geared specifically toward thought, planning, design, testing and, ultimately, implementation.  

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