Effortless Connectivity to Global UDI Databases.
Integrate once, connect everywhere. UDI Connect links your existing systems to global regulatory databases - no complex IT infrastructure required.
Refine Data Exchange. Streamline Compliance.
UDI Connect bridges your existing systems with global regulatory databases, automating data exchange and submissions to save you time and reduce complexity.
Connect Your Systems
Integrate UDI Connect with your existing ERP, PIM or RIMS systems using our API-based solution - no complex IT development required.
Automate Data Validation and Exchange
UDI Connect automatically validates your data against the latest regulatory requirements and prepares it for submission, eliminating manual errors.
Submit to Global Databases
UDI Connect submits your validated data to EU EUDAMED or US GUDID and other regulatory authorities with one click.
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Eliminate Complexity.
Simplify Compliance.
Managing UDI submissions across multiple regulatory authorities like EUDAMED, GUDID and others can be overwhelming. IT teams often struggle with building and maintaining complex integrations, while regulatory teams face manual processes and fragmented systems.
UDI Connect removes these barriers by providing a seamless, API-based solution for data exchange.
Global Connectivity
UDI Connect enables you to sync with all major regulatory databases globally.
Seamless Integration
UDI Connect integrates with your IT-systems (eg. PIM, RIMS, or ERP).
Getting Started with
UDI Connect
UDI Connect provides comprehensive API documentation and step-by-step integration guides to ensure a seamless setup experience. With automated workflows, global compliance support, and real-time updates, it simplifies the entire UDI submission process.
1. Sign Up and Explore
Begin by creating your account on UDI Connect. Our intuitive onboarding process ensures you’re set up in minutes, not hours.
2. Validate your Data
Upload your UDI data. The system validates your data against market-specific rules, flagging errors for easy correction.
3. Submit with Confidence
Publish your validated UDI records directly to regulatory databases like EUDAMED and GUDID, no manual uploads.
4. Monitor and Optimize
Track submission statuses in real time with our dashboard. Gain insights into your progress and identify improvements.
Enhance Compliance.
Save Time. Reduce Costs.
Reduce IT Complexity
Eliminate the need for custom IT solutions. UDI Connect automates data exchange and submissions, simplifying your compliance processes and reducing IT overhead.
Ensure Data Quality
No more manual data transfers or formatting errors. UDI Connect ensures compliance by validating your data before submission and maintaining audit-ready logs for full traceability during regulatory reviews.
Scale to New Markets Faster
With built-in support for global regulatory databases and a scalable architecture, UDI Connect helps you to launch products in new markets three times faster.
FAQ
Find answers to your questions about UDI Connect integration, compliance, and data security.
UDI Connect is a comprehensive SaaS solution designed to simplify UDI (Unique Device Identification) compliance for medical device manufacturers, importers, and distributors. Built as an API-first solution, it simplifies validation, submission, and monitoring processes, accelerating compliance and reducing errors while integrating seamlessly with existing systems.
UDI Connect supports compliance with EUDAMED (EU) and offers the opportunity to expand to other markets as GUDID (USA), AusUDID (Australia), IMDIS (South Korea), and CUDID (China). The solution actively tracks global regulatory changes to ensure you’re always prepared for new requirements.
UDI Connect is designed for quick adoption. With a 14 day free trial, you can explore the solution’s features risk-free. Detailed documentation, sample payloads, and expert support ensure you can start submitting data in minutes - no IT-heavy setup required.
We apply the latest validation rules for each market and update regularly to reflect regulatory changes.
UDI Connect is tailored for professionals in regulatory affairs, IT, and product management who need a reliable solution to manage and submit UDI data efficiently. Whether you’re a small med-tech company or a global enterprise, UDI Connect adapts to your needs.
UDI Connect eliminates manual processes by automating UDI validation, submission, and monitoring. Its API-first design integrates seamlessly with ERP and PLM systems, ensuring your data is always accurate, compliant, and ready for regulatory audits.
Absolutely. We use robust encryption and comply with industry security standards. See our Trust Center for more details.
UDI Connect is designed for Regulatory Affairs, Quality Assurance, and IT professionals. Its user-friendly interface makes it accessible to teams of all sizes. Whether you're managing compliance or integrating systems, UDI Connect meets your needs.
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Empower Your Compliance Journey with Our Trust Center and Resources
Quick Start Guide
Our Quick Start Guide makes it easy for you to get started: guiding you through setup, integration and submissions.
Trust Center
Easily access all essential legal documents and certifications. Everything you need is in one place, ready when you need it.
Regulatory Insights
Stay ahead of change. Get the latest insights on regulatory evolvements affecting your compliance strategies.
Simplify Compliance. Start Today.
Say goodbye to submission infrastructure hassles. UDI Connect eliminates the need for additional IT infrastructure, automating submissions to GUDID, EUDAMED, and many more UDI databases.