Regulatory
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eMDR Gateway set up
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eMDR Gateway set up
My client has the need to set up and begin submitting MDR’s. The guidance mentions an ESG Next Gen gateway. I have never set this up. Does anyone have experience with this and can provide some pointers.
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3 Replies
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Hi Jude. Yes, I can help you out – let’s connect directly!
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Hi Jude, happy to help as well. Here is a link to the FDA’s page for the ESG NextGen:
If you have additional questions or want further pointers, please reach out directly.
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Yeah hey Jude, seems like these guys have you in good shape, but there is an eSubmitter software you can download and after that you should he able to directly access the gateway from your desktop. But once inside, you can select the option for FDA form 3500A.
If you also need help with assigning any of the codes associated with any MDR, let us know – There are spreadsheets for those to reference
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