| AssurX Inc. Press Release |  |
AssurX eMDR (Electronic Medical Device Reporting) Update
Due to the overwhelming amount of questions we get asked about our upcoming eMDR (Electronic Medical Device Reporting) solution, we've put together this Q&A to let you know what we're up to:
December 2007
Question: Is AssurX going to have an eMDR (Electronic Medical Device Reporting) solution?
Answer: Yes
Question: When will it be available?
Answer: AssurX doesn't pre-announce product launch dates. But what we can say is we'll be ready with eMDR when the FDA is ready to receive them through their AS2 production system. Currently they are still in testing stage, and haven't gone live.
Question: Are you currently testing the eMDR system with the FDA?
Answer: Yes. In fact, we've also helped them solve a few irregularities with XML translation files, which have in turn helped all the vendors participating in this program.
Question: Has your testing been successful?
Answer: Yes, as we've hit all the milestones including receiving all acknowledgements, etc., from the FDA.
Question: Has anyone seen your system?
Answer: Yes, we did a live demonstration at our AssurX Summit user conference to all of our customers in attendance back in September 2007.
Question: Do you have customers who are testing the system as well?
Answer: Yes, we have several who are on board for testing.
Question: Other vendors are touting they've been working closely with the FDA. Has AssurX been doing the same?
Answer: Yes, we've been working with the FDA all along. We've also helped solve several irregularities we've found along the way. See above.
Question: Do you think the FDA will make eMDR mandatory?
Answer: Maybe. We'll have to wait and see what happens after the comment period scheduled for Q1 next year.
If you have any further questions, please feel free to contact Tamar M. June, VP of Marketing at 408-778-1376, ext. 705.
If you would like to be kept up to date about eMDR at AssurX, please send us an email at emdr@assurx.com.
