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The solution is built to help regulatory, quality, and master data teams address the increasing complexity of global UDI requirements. As a single source of truth, UDI Hub empowers MedTech companies to govern, validate, and prepare UDI data for regulatory submissions such as EUDAMED- well ahead of the 2026 deadlines.

“We’re proud to see our first customers using UDI Hub to confidently tackle EUDAMED and other regulatory challenges,” says Patrick Pfau, CEO of p36. “Their feedback has shaped every feature, ensuring that UDI Hub addresses real-world needs and delivers measurable value from day one.”

UDI Hub: Designed for Real-World MedTech Needs

• Centralizes all UDI data, bringing device information into one secure and compliant solution
• Validates UDI records against the latest EUDAMED requirements, highlighting data gaps before submission
• Supports bulk data management for portfolios ranging from hundreds to ten thousand devices, reducing risk and manual effort
• Enables cross-functional teams (regulatory, quality, master data, and IT) to work together efficiently and stay audit-ready

With UDI Hub, teams can reduce manual work, improve data quality, and move confidently toward regulatory deadlines. Early adopters are already experiencing a more reliable and transparent UDI process that adapts to their specific needs and challenges.

What’s Next?
With general availability, p36 invites additional MedTech manufacturers to join the UDI Hub community and prepare for upcoming regulatory milestones. The journey continues, with new features, expanded regulatory support, and ongoing innovation all on the horizon.

For more information about UDI Hub and how your team can get started, visit http://www.udihub.io or contact contact@p36.io.