UDI Management Software With Automated M2M Transmission
Centralize global UDI management and enable secure machine-to-machine transmission to EUDAMED and other regulatory databases.
The Problem
Eliminate Manual UDI Errors Across Markets
Global UDI requirements across EU MDR, FDA GUDID, NMPA, Korea, and Saudi Arabia create complexity that spreadsheets and portals cannot manage.
Manual processes lead to:
Version mismatches across regions
Duplicate data entry
Rejected submissions
Audit exposure and delays
Rimsys replaces disconnected workflows with a centralized, structured UDI data model.
Purpose-Built
Built Specifically For MedTech UDI Compliance
Rimsys is purpose-built for MedTech regulatory operations.
UDI is embedded into core workflows and connected to:
Product
Registrations
Submissions
Certifications
Outcomes
Operational And Compliance Benefits
90% +
Customers achieve more than 90% reduction in regional reporting time.
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Faster UDI submission preparation
Fewer rejected records
Automatic country-specific formatting
Faster product release across markets
Full audit traceability
Lower regulatory risk
M2M Cloud Solution
The M2M Connection To EUDAMED As A Cloud Solution
M2M transmission enables direct system-to-system UDI submission.
No manual portal uploads
Reduced duplication and errors
Secure API-based transmission
Scalable to additional authorities
Unified Data Model
UDI Connected To Registrations, Submissions, And Certifications
Show how UDI connects to:
Product registrations
Submissions
Certificates
Change impact assessments
ERP, PLM, Labeling integrations
Enterprise Spec
Built For Enterprise Regulatory Operations
Designed for complex MedTech environments:
Multi-entity and multi-country support
Complex product hierarchies
Role-based permissions
Audit trails
SOC 2 and ISO-aligned  security
Supports global teams operating at scale.
Trusted By Global MedTech Leaders
Rimsys is trusted by 6 of the top 12 global MedTech manufacturers to manage and scale regulatory operations.
Organizations using Rimsys achieve:
Faster submission and approval timelines
Improved data accuracy across regulatory systems
Significant reductions in manual reporting effort
Greater confidence in global compliance execution
See UDI And M2M Transmission In Action
FAQs
UDI management software centralizes the creation, maintenance, and submission of Unique Device Identification data across global regulatory authorities. It ensures data accuracy, traceability, and compliance across markets.
M2M transmission is the automated exchange of structured regulatory data between systems using secure APIs. It removes the need for manual portal uploads and reduces submission errors.
Structured UDI data is generated and maintained in Rimsys, then transmitted directly to EUDAMED through secure, authenticated connections. This ensures consistent and compliant data submission.
Centralized UDI data enables faster product registration, reduces duplication across markets, and ensures consistent compliance, allowing companies to scale into new regions with confidence.
Rimsys uses a structured data model and API-based transmission to connect directly with EUDAMED, enabling automated submission and reducing manual intervention.
Yes. Rimsys integrates with enterprise systems such as ERP, PLM, and labeling platforms to keep UDI and product data aligned across the organization.
Yes. Rimsys supports UDI data management and submission requirements for FDA GUDID and other global authorities as part of its Universal UDI capability.
Yes. UDI management is fully integrated within the Rimsys platform, connecting with registrations, submissions, and regulatory workflows to support end-to-end execution.
