EtQ Reliance eMDR Submission Tool enables
Medical Device Manufacturers
to electronically submit Medical Device
Reports (MDRs) to the Food and Drug
Administration (FDA). This methodology
allows companies to electronically automate
the quality process for medical device,
and comply with quality and FDA compliance
standards, including those of the FDA.
The FDA is working on an electronic
submission program called "emdr." This
program will enable companies to
submit MDRs to the FDA gateway, a secure
agency portal for electronic submissions.
Working with representatives from the FDA,
EtQ has developed a tool that
will allow users to electronically submit
MDRs to the FDA gateway, seamlessly
and efficiently.
Using the EtQ eMDR Submission Tool,
not only are users able to automatically
submit their reports directly to the
FDA, but it also provides a level of
functionality that ensures fewer submission
errors, tying the submission process
directly into the Complaint
Handling and Corrective
Action Preventive Action (CAPA)
workflows.
