Master UDI Compliance.
Lead Global Markets.
EUDAMED deadlines looming? Struggling to scale beyond a single regulatory authority?
UDI Hub is your ultimate compliance partner, empowering you to streamline operations and unlock global growth: automate your UDI-workflows, slash your rejections and expand faster into new markets.
Level Up:
Turn Complexity into Automated Efficiency
Transform your compliance workflows with automation that saves time, reduces errors, and empowers growth.
Smart Workflow
Automation
Manual processes slowing you down?
With built-in smart validations and error-proof processes, you can eliminate repetitive tasks and focus on strategic priorities: UDI Hub automates 80% of your compliance workflows.
Seamless Multi-Authority
Submission
Struggling with multiple portals?
With built-in data adaptation for each regulator, you can automate submissions across regulatory databases like EUDAMED: UDI Hub keeps your data ready globally.
Industry Leaders Who Trust p36 Solutions
Lead the Way:
Your UDI Compliance Dashboard
Empower your regulatory affairs team with real-time global compliance insights. Instantly spot compliant regions and risks in your interactive dashboard, so you can act fast, make smart decisions, and stay ahead anywhere, anytime.
Insights
With UDI Hub's interactive worldmap you can instantly identify gaps, prioritize actions, and stay ahead of evolving regulatory challenges.
Real-Time
UDI Hub’s dynamic dashboard tracks progress, flags issues, and provides actionable insights - when they occur - to keep you on track.
Beat the Clock:
EUDAMED Compliance on time
The EUDAMED deadlines are fast approaching - March 2026 for new products and September 2026 for existing ones. UDI Hub ensures your data is accurate, compliant, and submission-ready before it is too late.
Enhanced Data
Accuracy
UDI Hub continuously validates your data against the latest EUDAMED requirements, so you can catch and fix issues early. Meet EUDAMED's evolving standards - on time, every time.
Centralized Data Management
UDI Hub consolidates all your UDI data into a single source of truth, ensuring consistency and readiness for both new and existing product submissions. Ready for the first time, every time.
Getting Started
with UDI Hub
UDI Hub is built for easy self-onboarding. Get started instantly with our in-app guidance, a detailed step-by-step guide, and contextual help. Whether you’re handling hundreds of medical devices in a single market or just a few in multiple markets, UDI Hub makes compliance simple and efficient for you.
Connect & Import Your Data
Get started quickly with minimal IT involvement and import your data from existing spreadsheets.
Centralize & Organize
Consolidate all your UDI data into one secure, cloud-based system. Eliminate data silos and manual version control.
Validate for EUDAMED
Automated checks flag errors or missing information before submission, helping you avoid costly rework and rejection.
Collaborate
Tailor approval workflows, assign roles, track progress, and ensure every record is reviewed and approved.
Submit
Publish your validated UDI data directly - with one click - from UDI Hub to the regulatory database. (e.g. EUDAMED).
Monitor & Report
Track submission status, receive deadline alerts, and generate compliance reports .
FAQ
Get answers to your most pressing questions about UDI Hub and its capabilities.
UDI Hub is a comprehensive solution designed to simplify the management, validation, and submission of UDI (Unique Device Identification) data. It centralizes your compliance workflows, ensuring your data is accurate, compliant, and ready for regulatory submissions.
UDI Hub 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 Hub is a solution built to adapt to your business needs. With its intuitive interface, automation capabilities, and scalability, UDI Hub simplifies compliance workflows and grows with your regulatory requirements.
UDI Hub is designed for quick adoption. With in-app guidance, a detailed handbook, and contextual help, you can begin managing your UDI data in minutes. Whether you’re handling a single device or hundreds, UDI Hub makes compliance simple and efficient.
UDI Hub is ideal for medical device manufacturers, importers, and distributors who need a reliable way to manage UDI data efficiently. It’s tailored for professionals in regulatory affairs, IT, and product management, whether you’re part of a small team or a global enterprise.
UDI Hub streamlines UDI compliance by centralizing your data in one place. It validates your data against market-specific rules, organizes submissions, and tracks their status in real time. Built-in error checking ensures your data is compliant before submission, reducing risks and saving time.
UDI Hub includes dashboards and reporting tools that provide a clear overview of your UDI data and submission status. You can track pending or completed submissions, generate summaries, and export data for audits or internal reviews—keeping you informed and audit-ready.
UDI Hub provides extensive resources to empower users, including in-app guidance, best practices, and a detailed user guide / integration guide.
Still Got Questions?
Contact us
Empower Your Compliance Journey with Our Trust Center and Resources
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.
Customer Story
Read here how p36’s Expertise is transforming Global UDI Compliance.
Beat the Clock.
Master UDI Compliance.
The EUDAMED deadlines are fast approaching - March 2026 for new products and September 2026 for existing ones. UDI Hub ensures your data is accurate, compliant, and submission-ready before it is too late.
Join the UDI Hub Early Access Program. Be among the first to experience the future of UDI compliance.