From PilgrimSoftware.com
CDRH eMDR to be Made Mandatory. Are You Ready?
By
Nov 13, 2007,
11:00
Speaker: Deborah Kacera, Senior Product Manager, Pilgrim Software
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FDA is urging device manufacturers to voluntarily adopt the agency's electronic Medical Device Reporting (eMDR) process in anticipation of being required to do so as early as next spring. The program is intended to help FDA’s Center for Devices and Radiological Health (CDRH) more easily identify patterns in adverse events, as well as to reduce the overwhelming number of paper adverse event reports submitted by manufacturers.
The eMDR program is currently optional, but a draft rule mandating electronic reporting is being completed within CDRH and will likely be released for public comment by February, 2008. CDRH is expected to move the final rule forward very quickly.
Pilgrim has partnered with the FDA since the inception of its pilot program to modernize the data entry process for electronic reporting of adverse events. Pilgrim has been providing key insights into improving the robustness of the FDA’s eMDR technology through feedback sessions and rigorous testing to accommodate all adverse events scenarios that its customers experience, ranging from simple, to complex, to longer-term implantable medical devices scenarios.
The eMDR Electronic Submission capability is part of Pilgrim’s SmartComplaints solution that aids medical device manufacturers with the recording, processing, investigation and resolution of a complaint or Adverse Event.
Join Pilgrim Software to learn how you can:
- Set up a streamlined closed-loop process for complaint recording, investigations, root cause analysis, resolution and reporting
- Understand the new eMDR program
- Implement automatic easy medical device reporting for (eMDRs) of low- and high-volume submissions to the FDA, as well as EMEA, Canada, Japan and Australia
Through Pilgrim’s dedication in working with the FDA and the advancements in technology, medical device companies will be able to have their eMDRs rapidly transferred and approved, and reduce overall reporting errors and timing. Get prepared before "Optional" becomes "Mandatory!"
Who should attend this Webinar?
- RA/QA, IT, Product Surveillance
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