(Sparta Systems Inc.; Holmdel, New Jersey) Sparta Systems Inc., the maker of TrackWise, and an enterprise quality and compliance process management software provider, has released the Beta version of the TrackWise eMDR Submission Manager software. The add-on software enables medical device companies to electronically submit medical device reports (MDR) to the Food and Drug Administration. TrackWise eMDR Submission Manager is one component of Sparta’s current initiative to support the growing number of life sciences electronic submission processes, which are complementary to quality and regulatory solutions. Medical device manufacturers use TrackWise to electronically track and manage product complaint and adverse event assessment and reporting processes. The software enables device companies to effectively manage complaints and investigations, assess potential adverse events for safety risk problems, and comply with health authority reporting requirements, including those of FDA.

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