Manufacturers of Medical Devices must take action now in order to submit their Product Master Data to Unique Device Identification (UDI) Databases worldwide.
After the US Food and Drug Administration (FDA) the EU will follow with its Medical Device Regulation (MDR), becoming effective in May 2020 – it´s only a few months to go! Many countries more – e.g. China, India and Korea – are to follow, so it´s time for a strategic setup for UDI. projektraum36 provides the strategic answer for the UDI related processes. It is operated on SAP Cloud Platform (SCP) and offers a seamless integration into your existing SAP landscape. The UDI Platform allows the complete Maintenance, Validation and Submission of UDI related Product Master Data, handling various different Data Models of different Regulatory Authorities with their Validation Rules, different Data Formats and Submission Handlings.
Our Partner Chemgineering Business Design supports you with a Validation Package for the Validation and Qualification of the UDI Platform.