How to Automate the Transfer of Your Data to GUDID and EUDAMED
One of the challenges in meeting the requirements of the FDA or the European Commission is to transmit UDI data to the authorities in the correct format.
As a technology company, Europe IT Consulting offers a service to transform UDI data into the HL7 SPL format and transmit it to the authorities.
→ This allows you to interact with the authorities securely, with less pain and cost.
→ What options do I have as a customer?
1. Data Transfer with XML Files from SAP
Are you already using our UDI SAP Add-On to manage your medical device master data? Then you can either export the data to your local PC using the data export report and email us the XML files, or directly upload them to our cloud server.
We convert the XML files into the HL7 SPL XML format before transferring the data to GUDID.
2. Data Transfer with the UDI SAP Add-On directly from SAP
If you are already using our UDI SAP Add-On to manage your medical device master data, you can directly export and upload the data from your ERP system to our cloud server.
You will receive confirmation of successful upload to our cloud server directly through a RESTful WebService.
The UDI Add-On then automatically checks the status of the data transfer and the status on the regulatory authority’s database in the background, keeping you always up to date.
3. Data Transfer with UDI Excel Template
If you want a cost-effective solution for data transfer to EUDAMED and GUDID, you will likely be interested in our UDI Excel Template solution.
The UDI Excel Template serves as both a data container for your UDI data and as data input for our data transfer service.
You can purchase our UDI Template in the Products section:
By subscribing to our UDI Data Transfer Service, you can send us the Excel file with your data via email. We handle the machine-to-machine (M2M) data transfer. You will also receive feedback on the transfer and any error messages via email.