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UDI Submission Service

Submit accurate, comprehensive data to the GUDID
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WE MAKE THE PROCESS OF SUBMITTING UDI RECORDS TO THE FDA EASY AND EFFICIENT

Reduce the time and effort necessary to implement and maintain UDI submissions. With the UDI Submission Service, medical device manufacturers operate from a single platform to manage, submit, review, and update records. The FSEnet+ Platfrom audits information for accuracy before it is sent to the FDAs GUDID, and users receive automatic status notifications to ensure that data requirements and Class deadlines are met without the need for costly corrections.
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Capture information via file load or enter directly into an intuitive user interface
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Audit product information for submission accuracy and eliminate errors
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Submit UDIs to the GUDID through an AS2 secured connection
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Receive Acknowledgement Messages directly and make immediate revisions
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ADvantages oF USING FSEnet+ FOR UDI SuBMISSIONS

  • CAN BE COMBINED WITH GDSN, NHS, AND EUDAMED SUBMISSION SERVICES
  • SYSTEM STATUS NOTIFICATIONS ALLOW YOU TO TRACK DEADLINES
  • FLEXIBLE OPTIONS FOR INTEGRATING WITH YOUR BACKEND ERP SYSTEM
  • AUTOMATIC INFORMATION VALIDATION AND SUBMISSION OPTIMIZATION
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LEARN ABOUT OUR COMPREHENSIVE HEALTHCARE SOLUTION

ONE SOLUTION FOR UDI, NHS, EUDAMED, GDSN & MORE
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