eMDR

AssurX eMDR (Electronic Medical Device Reporting) is a closed-loop automated adverse event reporting solution designed for medical device manufacturers and device user facilities. It enables direct electronic submission of MedWatch 3500A reports to the FDA Gateway without requiring third-party tools or EDI systems, supporting full compliance with FDA CFR 21 Part 803 reporting guidelines for events involving device-related death, serious injury, or malfunction.

The solution uses an intuitive, tabular workflow approach to manage all levels of 3500A reporting, including direct submission to the FDA's Electronic Submissions Gateway (ESG) via WebTrader (WT) or AS2, as well as PDF generation. All submission acknowledgements are attached to the corresponding MedWatch record as they are received, and a dashboard on the eMDR home page provides at-a-glance status tracking.

FDA Submission and Acknowledgement Workflow

1. The FDA ESG receives the eMDR submission and sends Acknowledgement 1 to the submitter, confirming receipt and including a Message Integrity Check to validate the submission was received intact.
2. The submission is automatically transferred to the FDA Center, and the FDA ESG sends Acknowledgement 2 indicating the submission has reached CDRH.
3. CDRH validates and processes the submission and sends Acknowledgement 3 confirming the submission was successfully loaded into the Adverse Event database, or noting any validation or loading errors.
4. All three acknowledgements are attached to the MedWatch record as they are received, with status visible from the AssurX eMDR dashboard.

Key Features

• Complete end-to-end solution with all acknowledgements attached to each submission record
• Control over the entire MDR reporting cycle
• Built-in dashboards with real-time tracking for all MDR submissions
• Submission of 5-day and 30-day MedWatch reports, follow-up reports, and attachments
• Central management of tasks with notifications, escalations, rules, and reminders
• Reporting solutions for EU MDR and other countries, in addition to MedWatch 3500A
• PDF generation alongside electronic submission options

Integration with the AssurX Quality Ecosystem

• Integrates with other AssurX solutions or external systems to manage quality and change throughout the device lifecycle
• Supports launching related investigations for complaint management, deviations, and corrective and preventive actions (CAPA)
• Enables initiation of change requests, documentation updates, and modification of training requirements through connected processes
• Connects eMDR reports to product records in external systems to improve compliance visibility across the enterprise

AssurX eMDR is part of the broader AssurX platform, which centralizes quality management and regulatory compliance within a single configurable system. The platform includes pre-configured workflows for audit management, CAPA, complaint management, document management, risk management, supplier quality, training management, and more, supporting scalable deployment as organizational requirements evolve.