AssurX eMDR Automates FDA Medical Device Safety Reporting

AssurX eMDR provides a closed-loop automated reporting system for adverse event reporting without the requirement of any additional third-party tools or EDI systems. It enables full compliance with FDA CFR 21 Part 803 reporting guidelines for medical device manufacturers and device user facilities to report adverse events concerning device-related death or serious injury, or malfunction.

AssurX eMDR automates the generation and submission of electronic medical device reporting (eMDR) for MedWatch 3500A reports direct to the FDA Gateway. 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.

“We chose AssurX for its ease of use, the ability to configure the system to our workflow, zero client architecture for quick deployment worldwide, ease of integration with ERP systems such as SAP, as well as for its advanced query functionality.”

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AssurX manages submissions and acknowledgements through the FDA’s Electronic Submissions Gateway. All acknowledgements are attached to the MedWatch record as they are received. A dashboard provides at-a-glance acknowledgement status from the AssurX eMDR home page.

AssurX eMDR Automates FDA Medical Device Safety Reporting

Integrate eMDR into a Unified Quality Ecosystem

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.

Initiate change requests, update documentation, and modify training requirements through connected processes in the AssurX platform.

Connect eMDR reports to product records in external systems to improve compliance posture and visibility throughout the enterprise and creates a quality ecosystem focused on visibility, product safety/improvements, and customer satisfaction.

AssurX eMDR Key Features

  • A complete, configurable solution

  • Built-in dashboards with real-time tracking for all MDR submissions

  • Central management of tasks with notifications, escalations, rules, and reminders

  • Control the entire MDR reporting cycle

  • Submission of five (5) and 30-day MedWatch reports, follow-up reports and attachments

  • In addition to Medwatch 3500A, AssurX provides reporting solutions for EU MDR and Canadian Med Device Reports