EUDAMED and GUDID Integrated into your MedTech RIM
Regulatory operations should not rely on disconnected portals and manual uploads to stay compliant.
Rimsys connects your regulatory and UDI data directly to global authority databases—transforming fragmented submission processes into a governed, connected operation. As the heart of regulatory operations, Rimsys continuously links product data, registrations, approvals, and Universal UDI® attributes so your organization can execute with clarity, speed, and confidence.
Instead of duplicating data across spreadsheets and government portals, your teams work from a single, validated source of truth—reducing compliance risk while accelerating global expansion.
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The Problem
Manual UDI Submissions are Not Sustainable
EUDAMED and GUDID require structured, highly specific UDI data submissions.
Yet many MedTech organizations still manage UDI outside their RIM system—relying on spreadsheets, shared drives, and manual portal uploads.
The Result:
Duplicate data entry across systems
Version mismatches between product and UDI records
Increased audit exposure
Time-consuming validation cycles
Regulatory Operations and IT teams managing disconnected workflows
Architecture
System-Level Integration With Global UDI Databases
Rimsys enables structured, system-level integration with global UDI databases—eliminating fragmented submission workflows. This includes:
Capabilities
How Rimsys Enables EUDAMED And GUDID Integration
Rimsys unifies UDI, registrations, and product data inside a single regulatory operating platform. Key capabilities include:
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Reduce administrative burden and errors with Universal UDI®, which stores common UDI attributes and auto-generates country compliant formats for the US, EU, China, Korea, and more.
Built-in data validation ensures required attributes are complete and structured before submission—reducing rejection risk.
Authority-ready exports and integration workflows reduce manual handling and improve submission accuracy.
UDI records are directly linked to:
- Registrations module
- Submission workflows
- Product master data
When product data changes, Connect (Change Data Capture) identifies downstream impact—including UDI updates—so nothing falls out of sync.
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Impact
Reduced Risk, Increased Regulatory Velocity
When UDI data is governed inside the heart of regulatory operations, measurable outcomes follow:
- Significant reduction in manual submission time
- Reduced UDI errors and resubmissions
- Faster authority updates
- Improved audit readiness with real-time traceability
- Stronger IT governance over regulatory data
Customers using Rimsys routinely achieve measurable efficiency gains, including over 90% reduction in regional reporting time and regulatory release authorization in minutes instead of weeks, accelerating both compliance and growth.
Connected regulatory execution drives both compliance and growth.
Platform Advantage
Connected to the Broader RIM Platform
Unlike other RIM platforms, EUDAMED and GUDID integration within Rimsys is not a standalone feature.
It is:
Tied directly to governed product master data
Linked to submission workflows
Connected to change impact assessments
Embedded inside a structured, enterprise-grade data model
This is what differentiates Rimsys from systems that digitize individual tasks.
Rather than adding another portal integration, Rimsys creates a living, connected regulatory operation that keeps compliance work moving across teams and regions
Trusted By Global MedTech Leaders
Six of the world’s top 12 medical device manufacturers rely on Rimsys to manage global regulatory operations
Enterprise-ready. MedTech purpose-built. Proven at global scale.
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Modernize Your UDI Compliance Architecture
Manual portals and disconnected databases cannot support enterprise regulatory growth.
It’s time to:
Centralize UDI and regulatory data
Govern product attributes with precision
Integrate directly with global authorities
Reduce risk while accelerating expansion
FAQs
EUDAMED integration connects structured product and UDI data from a RIM platform directly to the European database, reducing manual uploads and improving data governance.
GUDID integration enables structured UDI data to be validated within the RIM system and prepared for submission to the FDA’s GUDID database through controlled export or API-based workflows.
Where supported by authority infrastructure, API-based integration enables structured synchronization. Otherwise, validated authority-ready exports reduce manual handling and submission risk.
Portal upload requires manual data entry or file upload into authority systems. System integration connects governed regulatory data directly from the RIM platform, reducing duplication and errors.
Rimsys supports structured UDI data management aligned to EUDAMED requirements and enables integration workflows designed to reduce manual portal dependency.
Yes. Rimsys supports controlled validation, structured exports, and integration processes that streamline GUDID submissions.
UDI attributes are governed inside Rimsys’ structured data model with built-in validation logic, ensuring required data is complete and audit-ready prior to submission.
UDI management and integration capabilities are embedded within the broader Rimsys RIM platform—connected to product data, registrations, submissions, and change management workflows.
