we make the process of submitting udi records to the fda easy and efficient
SINGLE platform, total MANAGEMENT

With the FSEnet+ UDI Solution, Users operate from a single platform to manage, submit, and review records.

TRACK DEADLINES WITH NOTIFICATIONS

Receive automatic notifications in your inbox regarding the status of your UDI submissions to keep you on track to meet Class deadlines.

EXPAND TO GDSN, NHS, EUDAMED

The FSEnet+ System is more than just UDI and your portal can be expanded to accommodate GDSN, NHS, Eudamed and other requirements.

FLEXIBLE INTEGRATION WITH GUDID

With both file-based integration and a powerful User Interface, Users can create a direct line of communication between their back end systems and the Global Unique Device Identification Database (GUDID)

SAVE TIME AND RESOURCES

Reduce the time and effort necessary to implement and maintain your UDI process. With the FSEnet+ UDI solution there is no need develop, maintain, or host your own HL7 SPL connection.

STREAMLINED DATA SUBMISSIONS

The FSEnet+ Platform validates your data for attribute accuracy and optimizes it for HL7 SPL submission to the GUDID. The FDA gets clean, accurate data and you save on costly, time-consuming resubmissions.

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SIMPLE INTERFACE FOR MANAGING UDI SUBMISSIONS

The FSEnet+ SaaS application is a simple and intuitive platform that takes the guesswork out of submitting UDI information to the FDA.

  1. CAPTURE Enter device information directly in our intuitive User Interface or via file upload.
  2. AUDIT Mitigate risk, reduce costs, and minimize IT resources with built-in audit functionality that allows you to discover potential problems in real time.
  3. SUBMIT Send device information directly to the GUDID through an AS2 secured connection.
  4. ACKNOWLEDGE Receive Acknowledgment Messages (ACK 1, ACK 2, ACK 3) directly from your FSEnet+ Portal and make immediate revisions without the need to log in to the GUDID.
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LEARN ABOUT OUR COMPREHENSIVE HEALTHCARE SOLUTION
ONE SOLUTION FOR UDI, NHS, EUDAMED, GDSN & MORE
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