Already Established UDI
Governance Processes?

Navigate the complexities of global regulations with ease:
UDI Connect brings your processes across the finish line to global markets like
US (GUDID), EU (EUDAMED), China (CUDID) or Australia (AusUDID) by automating validations and submissions - all with one seamless API-driven solution.

UDI Connect Status UDI submissions. UDI Connect API dashboard displaying validation and submission endpoints, success/error metrics, and interactive analytics for regulatory affairs,
 legal and IT teams.

Managing Global UDI Connectivity Is Hard...

Diverse Market Requirements

Each regulatory database (e.g. EUDAMED, GUDID) has unique rules and validation criteria with frequent updates.

Data Silos and Fragmentation

UDI data is scattered across different systems like ERP, PLM, RIMs, and others, there is no single source of truth.

Time-Intensive
Workflows

Time-Intensive Workflows

Manual validation, submissions, and tracking consume valuable time, and repetitive tasks increase risk.

... And Doing It On Your Own, Manually, is Even Harder

Complexity

Regulations are constantly evolving, making it difficult to stay compliant manually.

Resource Constraints

Teams lack the bandwidth to manage compliance while focusing on strategic priorities.

Risk of Errors

Manual processes are prone to mistakes, delaying product launches and risking penalties.

Connect. Submit. Done. UDI Compliance Your Way

UDI Connect’s API-driven approach bridges the last mile to global regulatory databases by:

Integration

Connect with your own developed or standard systems like ERP, PLM, or RIMs.

Automation

Reduce IT workload by automating validation, submission, and monitoring.

Security and Compliance

Ensure secure data handling with audit-ready logs and regulatory alignment.

Real-Time Monitoring

Gain visibility into submission statuses and compliance with instant updates.

Scalability

Adapt to evolving regulations and new markets with dynamic schema mapping.

Industry Leaders Who Trust p36 Solutions

Roche Diagnostics
Sarstedt
Schülke & Mayr
Kulzer
Novo Nordisk
CooperVision
GHD FORLIFE
Raumedic
Karl Storz
Roche Diagnostics
Sarstedt
Schülke & Mayr
Kulzer
Novo Nordisk
CooperVision
GHD FORLIFE
Raumedic
Karl Storz
Roche Diagnostics
Sarstedt
Schülke & Mayr
Kulzer
Novo Nordisk
CooperVision
GHD FORLIFE
Raumedic
Karl Storz
Roche Diagnostics
Sarstedt
Schülke & Mayr
Kulzer
Novo Nordisk
CooperVision
GHD FORLIFE
Raumedic
Karl Storz

Let's Elevate Your Robust UDI Processes with UDI Connect.

Multiple portals, diverging requirements, and evolving regulations from different regulatory databases (like GUDID or EUDAMED) are slowing you down. And ensuring your data is accurate before submission is challenging, often causing manual work, errors, and delays.

UDI Connect bridges exactly this last mile for you by validating UDI data in real time, integrating with your systems to ensure error-free submissions, reducing manual effort, and keeping you ahead of regulatory changes.

Rapid Onboarding

Get started fass. Your team is up and running in minutes, with guidance available when you need it.

Global Compliance

Always be on top of regulatory evolvements and submit to multiple authorities.

Time Savings

Focus on your strategic priorities by reducing manual effort on repetitive tasks.

How it works

Experience a new era of global UDI compliance with UDI Connect. Our solution automates the validation and submission processes across different regulatory authorities. Say goodbye to manual errors and hello to worldwide markets.

1. Connect Instantly

Prepare your UDI data. Connect your systems easily with global regulatory database via API-interface  and upload your data.

2. Validate Automatically

Uncover errors by automated validation checks against
market-specific requirements.

3. Submit Effortlessly

From EUDAMED to AusUDID: Submit directly to the required regulatory database - error-free and on time.

4. Track & Optimize Continuously

Track submission statuses in real time within your own systems. Gain insights into your progress and identify improvements.

Achieve Global UDI Compliance with UDI Connect

UDI Connect simplifies the complexities of global UDI compliance, enabling you to manage, validate, and submit UDI data seamlessly across multiple markets.

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