AssurX eMDR provides a closed-loop, end-to-end automated reporting system without the requirement of any additional third-party tools or EDI systems. Everything is built-in, ready to go. MedWatch 3500A and other vigilance reports can be generated and submitted directly from the system. The solution delivers improved on-time reporting that also substantially improves accuracy and productivity in your reporting process.
Control of the entire MDR reporting cycle Built-in dashboards with real-time tracking for all MDR submissions
Complete end-to-end solution—no need for 3rd party tools or components
Submit 5- & 30-day MedWatch reports follow-up reports and attachments
Central management of tasks with notifications, escalations, rules and reminders
Support for US Med Device Baseline, EU Vigilance and Canadian Med Device Reports.
The entire MedWatch 3500A process is pre-built and ready to use out of the box. Simply enter the medical device company’s manufacturing ID and general default values such as address information to get started. No additional configuration is needed—users can start using the process and submitting to the FDA. For medical devices companies, eMDR (electronic medical device reporting) is fully integrated, allowing MedWatch 3500A and other vigilance reports to be generated and submitted directly from the system.
One QMS Platform Delivers Every Solution for Medical Device Manufacturing
AssurX quality management system software and eMDR is designed to support requirements and standards for the FDA regulated medical device manufacturing industry. The solutions seamlessly integrate, creating an ironclad closed-loop system to identify, track, resolve, document and report all quality and compliance issues across every part of operations—even into the supply chain.
The AssurX platform offers an easy-to-use, flexible, integrated system of quality management solutions that are designed for FDA-regulated companies.
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