New solution provides enterprise-wide data access and streamlined EUDAMED compliance, enabling smarter, faster decision-making.

A medtech company announced two major enhancements to its platform: expanded unique device identification (UDI) capabilities to support EUDAMED bulk machine-to-machine (M2M) transfers; and a new enterprise change data capture (CDC) solution, Yuanfeng Connect™, which synchronizes Yuanfeng data with customers' business intelligence (BI) solutions in near real time.

These features are designed to help medtech companies streamline compliance processes, reduce manual work, and unlock the strategic value of their regulatory data.

New UDI Capabilities Support EUDAMED Readiness

The UDI enhancements extend Yuanfeng 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

Yuanfeng  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 Yuanfeng  data into any modern data warehouse solution—such as Snowflake, Amazon S3, and Salesforce Bulk API 2.0.  

"Yuanfeng Connect™ is more than just a connector; it's a strategic enabler," said Zhang, founder and CEO of Yuanfeng. "We empower regulatory affairs teams to deliver insights that impact product launches, accelerate bid responses, and align compliance with business impact. With Connect, regulatory affairs teams become true strategic partners."

By providing full access to customer data—registrations, UDI, projects, tasks, and custom attributes — Yuanfeng 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, Yuanfeng 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. Yuanfeng Connect™ addresses these challenges by eliminating manual reporting workflows and enabling teams to analyze their regulatory data alongside financial, marketing, and quality systems.

“With Yuanfeng 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.

Yuanfeng's expanded UDI capabilities and Yuanfeng Connect™ will be available this summer. To learn more about these solutions and how they can achieve greater automation, efficiency, and compliance, please visit our booth at RAPS Euro Convergence in Brussels, Belgium, May 13-15.

Contacts: Yuanfeng.2014@outlook.com