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Sparta Systems(TM) Outlines Tips and Tactics to Prepare for eMDR Mandate
Date:6/16/2009

Suggested Best Practices will Prepare Medical Device Manufacturers to Comply with Expected Legislation and Drive Continued Innovation of Critical Healthcare Products

HOLMDEL, N.J., June 16 /PRNewswire/ -- 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 advance of the regulatory mandate. 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.

Sparta Systems has been in close communication with the FDA as the proposed legislation has been refined, and proactively provides its customers with an enterprise-wide quality management system that allows for a seamless transition from the current paper-based system to an electronic submission model. These suggestions for proactive eMDR compliance will not only help reduce associated compliance costs, but should also serve to streamline manufacturing processes, help ensure the safety of medical devices and foster customer loyalty. These suggestions include:

  1. Thought - Before any system can be designed, a thorough, candid self-evaluation is required for companies to understand the scope and nature of their businesses' eMDR needs. Initial
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SOURCE Sparta Systems, Inc.
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