Bad Hersfeld – April 7, 2021
The RAUMEDIC Group has been manufacturing medical quality products made of thermoplastic polymers and silicones for more than 70 years with about 900 employees worldwide. RAUMEDIC is currently preparing for the upcoming European Medical Device Regulation (EU MDR). In order to be able to strategically meet the corresponding requirements on Unique Device Identification (UDI), as well as future UDI requirements of other regulatory authorities worldwide, RAUMEDIC has decided to implement the UDI Platform from p36 GmbH.
The UDI Platform is a modern software-as-a-service solution that enables medical device manufacturers to implement data governance and transmission of UDI-related data to regulatory authorities worldwide. As an important component in the SAP Industry Cloud for Life Sciences, p36 GmbH offers a managed service for UDI.
The recently started implementation project at RAUMEDIC foresees the parallel implementation of Content Packages for EC EUDAMED and FDA GUDID. This will enable RAUMEDIC to obtain UDI compliance for the USA, to implement it for the European market in a timely manner, and will also provide the basis for other markets targeting global UDI compliance.
In collaboration with the consulting team of p36 GmbH, RAUMEDIC has already analyzed its master data in guided workshops and, based on the results, has already defined its future internal maintenance processes for UDI-related master data. The project team is currently configuring the target workflows, data models and user interfaces within the UDI Platform to tailor them to customer-specific needs. The special feature here is the unique “Common Device Model” concept, which can save up to 70% of data maintenance activities.
The next project phase of the implementation project includes the integration of the UDI Platform into the existing system landscape of RAUMEDIC. The interfaces are used for updating master data in the UDI Platform based on changes in the ERP system as well as handing data maintained in the UDI Platform back to the ERP system.
Finally, the migration of the master data already submitted to FDA GUDID database to the UDI Platform will take place on the basis of a standardized migration template.
After successful go-live, RAUMEDIC will be able to start with the data preparation, according to the attributes and validation rules required by EUDAMED and GUDID; the transmission of the UDI-related data to GUDID will then take place entirely with the help of the UDI Platform. As soon as the data transmission to EUDAMED will be possible through an M2M interface, current schedule of the European Commission is September 2021, RAUMEDIC will also be able to supply EUDAMED with UDI data.
Find out how we handled the project at p36 and get an insight into RAUMEDIC’s success story based on the UDI Platform.