Data submission easily done with our services
Data submission to EUDAMED and GUDID
One of the challenges in implementing the requirements of the FDA and the European Commission is to transfer the UDI data to the authorities in the correct format.
As a technology company, Europe IT Consulting offers a service to transform the UDI data into the HL7 SPL format and to transfer it to the authorities.
→ This allows you to interact with the authorities in a safe and secure manner, with less pain and cost.
→ What possibilities do I have as a customer?
1. Data transfer with XML files from SAP
You are already using our UDI SAP Add-On to manage your medical device master data ?
Then you can either use the data export tool in SAP to extract the data as an XML file or use the UDI data transfer tool in SAP to store the data directly on our server without detours.
We convert the XML files to HL7 SPL XML format before transferring the data to GUDID.
2. Data transfer with the UDI SAP Add-On directly from SAP
If you already use our UDI SAP Add-on to manage your medical device master data, you can use the data export and simultaneous upload to our cloud server directly from your ERP system.
Through a RESTFull WebService, you will receive direct confirmation of the successful upload to our cloud server.
The UDI add-on then automatically queries the status of the data transfer and the status on the authority database in the background, so that you are always up to date.
3. Data submission using our UDI Excel Template for EUDAMED or FDA
If you want to have easy and a low budget solution, the you can choose the UDI Excel Template file. Combined with our service which converts the UDI Excel Template into a XML files according the requirements for EUDAMED or FDA you are ready to submit your UDI data easily.
For that solution you need to purchase our UDI Excel Template file and subscribe the submission service.
Are you interested?