Case Study: RAUMEDIC achieves global UDI compliance with SAP Business Technology Platform

Using One Integrated Solution to Manage Medical-Device Compliance Complexity Globally

RAUMEDIC, a medtech company specializing in medical-grade polymers, needed to prepare for new EU medical device regulations and establish global compliance with unique device identification (UDI) standards. The company sought a solution to manage all UDI-related processes and create a single source of truth for its master data, connecting to its existing hybrid IT landscape. They partnered with vendor SAP and implemented a UDI governance solution from p36 GmbH built on the SAP® Business Technology Platform.

The SAP solution created one integrated system to manage UDI master data and compliance, enabling RAUMEDIC to successfully meet U.S. FDA requirements and prepare for the European EUDAMED database. The project established a single source of truth for global UDI data, readied the business for future regulations, and enabled a 70% re-use of existing data for submissions to authorities.

RAUMEDIC

Sebastian Deeg

Head of Information Technology