Request Webinar Replay – The FDA’s eMDR Mandate: Are You Compliant?


According to FDA’s 21 CFR Part 803 Electronic Reporting for Medical Device Adverse Event Reporting (FDA eMDR), all medical device companies are required to electronically submit their adverse event Medwatch Form 3500A to FDA.

No other method of submission will be accepted.

In this Webcast, you will learn how you can electronically submit and manage your adverse event reports integrated with a complaints management process to better holistically manage and control your adverse event reporting.


  • Overview of the electronic submission process using HL7 / ESG
  • Workflow process of an electronic submission
  • XML Generation and Submission to FDA
  • Integration to another EQMS process
  • Demonstration of the management of adverse events within a complaints management process



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With decades of expertise built into our quality management and regulatory compliance software platform, AssurX helps companies maintain quality and compliance, streamline workflow, control risks and better manage your enterprise. Our configurable software and deep understanding of users’ needs produce a unique system that easily adapts as your business evolves.

AssurX is an ideal partner for regulated companies looking for better operational control and efficiency while meeting and exceeding compliance standards.

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