Product Releases

Software Solution Helps Med Devices Comply with FDA Ruling

Fri, 10/18/2013 - 2:54pm
MDT Staff

Sparta Systems announced the release of TrackWise UDI eSubmission Manager. TrackWise is the company’s award winning EQMS that is used by leading medical device companies for complaint handling, adverse event reporting, non-conformance investigation, Corrective Action/Preventive Action (CAPA), registration tracking, and other quality and regulatory processes. The release marks Sparta’s fifth supported electronic reporting standard which includes support for eMDR and eMDV electronic submission processes.

The new FDA ruling calls for labelers to submit product information concerning medical devices to FDA’s Global Unique Device Identification Database (GUDID), unless they are subject to an exception. Specifically, it requires that product registration data is packaged and submitted to GUDID using XML transport and delivery.

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