From Complexity to Clarity:
Master EUDAMED Compliance
Tackle EUDAMED compliance with confidence:
Streamline your regulatory workflows, minimize errors, and adapt to changing requirements with ease.
EUDAMED Deadlines Approaching
The clock is ticking on MDR and IVDR compliance. Now’s the time to centralize your data, automate your submissions, and simplify every step. Always be ready for the next regulatory deadline.
Staying Ahead of MDR & IVDR DeadlinesBe prepared for every milestone. Streamlined, automated workflows make it easy to keep your submissions on track and your compliance up to date.
Breaking Down Data SilosBring all your data together. Integrate seamlessly with your existing systems and get a single, reliable source of truth.
Simplifying Submission OverheadReduce manual effort and errors. Automated processes handle submission formats and regulatory requirements, cutting down on time and complexity.
Navigating EUDAMED Hierarchy ComplexityEliminate confusing parent-child mappings. Dynamic validation keeps you compliant with even the most complex EUDAMED requirements.
UDI Connect and UDI Hub
Pick the right fit for your UDI Compliance
EUDAMED mastered -
UDI Submissions solved
UDI Connect bridges the crucial last mile to EUDAMED. From automated validation and submissions to real-time monitoring, No more disruption of your daily operations, no more submission struggle. Simply compliant.
Automate UDI workflows
for EUDAMED
UDI Hub simplifies EUDAMED compliance from end to end. The solution centralizes compliance processes for regulatory databases. Automate your data preparation, submission, and tracking to streamline your UDI workflows.
Industry Leaders Who Trust p36 Solutions
Overcoming the Key Challenges
in UDI Compliance
Tackle fragmented data, complex submission workflows, and evolving regulations. Streamline processes and ensure compliance.
Centralized Data Management
Automated UDI
Submissions
Smart Validations,
Audit-Readiness
Streamlined EUDAMED Process
UDI Connect is your solution for an API-first integration into your existing UDI IT-landscape: directly automate the validation and submission of UDI data - bridging your last mile to EUDAMED.
UDI Hub is your centralized solution that simplifies UDI compliance by acting as a Single Source of Truth: streamline data management, validation, and submission processes across multiple regulatory authorities, including EUDAMED.
Manage Basic UDI Data
Create and manage Basic UDI-DIs (BUDI) and associated data attributes with ease.
Assign Medical Devices
Simplify hierarchy management, including Basic UDI-DI and parent-child relationships.
Automate Submission
Streamline initial and updated submissions for Basic UDI and UDI-DI levels, reducing manual effort.
Monitor Progress
Track your submission status and receive alerts to stay ahead of critical deadlines.
Advance Your EUDAMED Compliance with Confidence
Simplify EUDAMED
Compliance
Automated validation ensures that your data meets EUDAMED’s strict requirements, resulting in reduced number of errors and rejections.
Simplify EUDAMED
Processes
One-click submissions and bulk data management eliminate manual portal navigation and delays, saving time for large device portfolios.
Simplify EUDAMED
Audit-Readiness
Pre-submission checks catch errors early, while comprehensive logs and exportable reports ensure audit-readiness and regulatory transparency.
Simplify Compliance. Start Today.
The EUDAMED deadlines are fast approaching - March 2026 for new products and September 2026 for existing ones. Ensure your data is submission ready before it's too late.