FDA eMDR Electronic Medical Device Safety Reporting
By using an intuitive, tabular workflow approach, AssurX provides all levels of 3500A reporting, seamless direct submission to the FDA’s ESG (Electronic Submissions Gateway) via WebTrader (WT) or AS2, as well as PDF generation. AssurX eMDR integrates with any other AssurX solution or external system to manage quality and change throughout the device lifecycle. Launch related investigations for complaint management, deviations and corrective and preventive actions. improve compliance posture and visibility throughout the enterprise and create a quality ecosystem focused on visibility, product safety/improvements and customer satisfaction.