In April, we informed about the provision of the UDI Platform for the RAUMEDIC Group to prepare for the EU MDR. At this time, the project team was working on the configuration of the target workflows, data models and user interfaces within the UDI Platform to tailor them to customer-specific needs.
Meanwhile, the Solution Management team integrated the UDI Platform into the existing IT-landscape of RAUMEDIC and migrated already submitted master data from FDA GUDID database to the UDI Platform, by using a standardized migration template.
We are very happy that the UDI Platform now plays an integral role in the process landscape of RAUMEDIC. By tying the labelling process to the UDI data governance process, the full power of an SAP industry cloud solution like the UDI Platform becomes visible. Data maintained and approved in the UDI Platform is automatically transferred back to the ERP system and used as labelling content for UDI compliant labels.
After RAUMEDIC has had the opportunity to test the platform thoroughly, they are now able to start with their data governance processes for FDA (GUDID) and EC (EUDAMED). Concretely, this means for FDA, that the transmission of UDI-related data to GUDID takes place entirely with the UDI Platform. As the team has already integrated the Content Package for EC EUDAMED, RAUMEDIC is now also able to prepare its UDI data for Europe within the UDI Platform. The submission to the EUDAMED database will be possible as soon as the M2M interface is ready. We will keep you updated as soon as we have more information on this.
Find out how we handled the project at p36 and get an insight into RAUMEDIC’s success story based on the UDI Platform.