Inefficient medical device reporting presents a clear and present danger: It can damage your company’s reputation and even threaten your ability to operate. After sending some mixed signals in the second half of 2007, FDA eMDR experts have said they’ll mandate eMDR within two years. The only debate now is how quickly it will happen, and what kind of extension smaller device companies may get.
It’s therefore not surprising to learn the agency is pushing harder for eMDR (electronic medical device reporting) than anyone else. By attending this Webinar, you'll learn more about the future of eMDR, the options available to you now, and why it makes good business sense to implement an electronic medical device reporting system today.
Agenda
Understanding Electronic Medical Device Reporting (eMDR):
- Making the switch from manual to fully automated electronic reporting
- What the FDA is saying about eMDR and the options available to you today
- Why implementing an eMDR system now makes good business sense
- The FDA's ESG (Electronic Submissions Gateway) and how it works for both low and high volume submissions
- Simple steps to getting started with the FDA's eMDR program
- The benefits of true eMDR and developing an effective strategy
AssurX eMDR™ Live Demonstration
- See how a true eMDR solution delivers improved ontime reporting, and how it can substantially improve accuracy and productivity.
- AssurX eMDR provides a closed-loop end-to-end solution without the requirement of any additional third party tools or EDI systems. Everything is built-in, ready to go.
Q&A Session
- Get your eMDR questions addressed by the experts in a live Q&A forum.
Who Should Attend
The Webinar will benefit those professionals who are involved in:
- Regulatory Affairs & Compliance
- Product Surveillance
- Quality Management
- Information Technology
Schedule
Please join us for this free 1 hour session that will include a 45 minute presentation by the featured speakers, followed by an interactive Q&A session.
Join Us
May 8, 2008 - 10:00 AM Pacific/1:00 PM Eastern
To register for this Webinar: http://www.assurx.com/eMDRSignup.html
About AssurX, Inc.
AssurX, Inc. provides global organizations with enterprise quality management and regulatory compliance solutions. AssurX’s flexible, all-in-one platform automates quality management and regulatory compliance related processes so issues can be globally managed. It helps collect, organize, analyze and share information to better manage and improve quality and compliance performance everywhere in your enterprise. A proven leader as the industry’s system of choice at companies around the world, AssurX solutions are available as either OnPremise or OnDemand (SaaS). AssurX is headquartered in Morgan Hill, CA.
