Rimsys, Pittsburgh, Regulatory Information Management (RIM) software platform for medical technology companies released an automated solution to address the global Unique Device Identification (UDI) requirements. This enhancement to the Rimsys ecosystem is immediately available to new and existing customers, providing a compliant method for tracking and traceability of UDI data that is fully compatible with global health authority databases.
UDI is a global harmonization effort to provide more consistent data that benefits overall product traceability throughout the medical device supply chain. It aims to adequately identify medical devices from manufacturing through distribution to patient use. Because global markets have different UDI requirements, product data can become a maintenance nightmare, even for the most mature medical technology companies. Data management is further complicated as UDI data is not static and must be updated based on changing regulatory requirements, such as market dates and registration status.
“Rimsys is the first automated UDI solution to fully integrate into a product’s registration lifecycle, ensuring that changing regulatory information is properly captured, registered, and maintained with the product and within government UDI databases like the GUDID (USA) and EUDAMED (EU),” says James Gianoutsos, founder and president at Rimsys Inc. “The current solutions landscape revolves around creating in-house, custom, and expensive projects with custom-built software or existing ERP software that were not designed to keep up with the fast paced and ever-changing regulatory landscape.”
In order to stay compliant and competitive, medical technology companies need to adapt quickly and flawlessly to the regulatory environment. As UDI requirements are rolled out across the globe, Rimsys’ UDI module seamlessly integrates with product registration data that is already actively managed within Rimsys, resulting in less maintenance, reduced costs, better compliance, and ultimately decreased time-to-market, according to the company.
“We have already seen how our system has helped world-leading medical technology companies, such as Johnson & Johnson, Omron, and Terumo, digitize, automate, and navigate the global regulatory landscape,” says Brad Ryba, chief technology officer at Rimsys Inc. “As these requirements and demands continue to evolve, we are committed to ensuring that regulatory professionals can leverage the data integrations within Rimsys to more proactively manage their regulatory information.”