New solutions deliver enterprise-grade data access and streamlined EUDAMED compliance, driving smarter, faster decisions across the business

Pittsburgh - April 29th, 2025 - Rimsys, the global leader in Regulatory Information Management (RIM) software for the MedTech industry, today announced two major enhancements to its platform: expanded Unique Device Identification (UDI) capabilities to support EUDAMED machine-to-machine (M2M) bulk transmission and Rimsys Connect™, a new enterprise Change Data Capture (CDC)  solution that provides near real-time synchronization of Rimsys data with customers’ Business Intelligence (BI) solutions.

Together, these capabilities are designed to help MedTech organizations streamline compliance, reduce manual effort, and unlock the full strategic value of their regulatory data.

New UDI Capabilities Support EUDAMED Readiness

The UDI enhancements extend Rimsys’ industry-leading Universal UDI® framework, enabling MedTech teams to manage complex, global UDI programs in one unified RIM system. Key new capabilities include:

• Approving multiple records simultaneously via a simple, scalable workflow

• EU data governance support with all required attributes for EUDAMED transmission

• Bulk submission of records to both the GUDID and EUDAMED databases

These features allow teams to eliminate time-consuming, record-by-record processing, helping them meet the mandatory January 2026 EUDAMED compliance deadline with confidence.

“We’ve partnered closely with our customers to develop a UDI offering that meets increasing regulatory complexity and is easily scalable as new regulations come online,” said Adam Price, Director of Regulatory and Technical Programs at Rimsys. "We’re not only giving customers the ability to meet EUDAMED compliance but enabling them to manage their global UDI program in a single-sourced RIM solution for complete visibility.”
 

Introducing Rimsys Connect™: Enterprise Data Access, Redefined

Rimsys Connect™ offers enterprise customers a powerful new way to leverage regulatory data across the business. Built on a scalable, event-driven architecture, it provides secure, structured, near real-time streaming of Rimsys data into any modern data warehouse solution—such as Snowflake, Amazon S3, and Salesforce Bulk API 2.0.  

“Rimsys Connect™ is not just a connector—it’s a strategic enabler,” said James Gianoutsos, Founder and CEO of Rimsys. “We’re giving regulatory affairs teams the ability to deliver insights that influence launches, accelerate tender responses, and align compliance with business impact. With Connect, RA teams become true strategic partners.”

By providing full access to customer data—registrations, UDI, projects, tasks, and custom attributes — Rimsys Connect™ supports a wide variety of enterprise use cases with customers’ own business intelligence solutions:

• Tracking on-time submission and decision KPIs

• Aligning registration timelines with product launch dates

• Conducting ROI analysis for renewals and market prioritization

• Accelerating tender readiness by combining RIM and PLM data

• Supporting post-market surveillance dashboards

While the initial release will focus on data access, Rimsys plans to expand Connect with curated BI templates and best practices to further accelerate enterprise customer time-to-value.

Solving the Data Fragmentation Problem for MedTech

Many regulatory affairs teams remain constrained by outdated tools, fragmented data sources, and increasing demands to deliver strategic insights to executive and commercial stakeholders. Rimsys Connect™ addresses these challenges by eliminating manual reporting workflows and enabling teams to analyze their regulatory data alongside financial, marketing, and quality systems.

“With Rimsys Connect™, regulatory teams can visualize and analyze their data in real time, assess launch readiness, and deliver more value to their organizations. This is how RA becomes a catalyst for better decisions—not just compliance,” said Gianoutsos.

Both Rimsys’ expanded UDI capabilities and Rimsys Connect™ will be available this summer. Those interested in learning more about these solutions and how they will enable greater automation, efficiency, and compliance can visit our booth at RAPS Euro Convergence May 13-15 in Brussels, Belgium, or sign up for Rimsys’ product update webinar on Thursday, May 22^nd at 10 AM ET.

Read the press release here.
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About Rimsys

Rimsys is improving global health by accelerating delivery and increasing availability of life-changing medical technologies. Rimsys Regulatory Information Management (RIM) software digitizes and automates regulatory activities, helping MedTech regulatory affairs teams to plan more effectively, execute more quickly, and confidently ensure global regulatory compliance. Rimsys is designed around MedTech workflows and supports a full breadth of regulatory activities including registrations, submissions, UDI, essential principles, and standards management in a unified platform. For more information, visit www.rimsys.io.  

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Contacts:

marketing@rimsys.io

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