udihub.io
UDI Hub & UDI Connect offer automated UDI compliance solutions, simplifying data centralization, submission, and global regulatory database integration for EUDAMED.
UDI Hub & UDI Connect provide automated solutions to centralize UDI data, automate submissions, and ensure global compliance effortlessly. They cater to tech-driven teams needing API-first integration and those seeking an all-in-one solution for UDI management. These services streamline the entire UDI workflow, from data validation to submission, simplifying compliance with global regulatory databases like EUDAMED. Trusted by companies to enhance efficiency and ensure compliance.
About
udihub.io provides automated UDI compliance solutions designed to streamline data centralization, submission, and integration with global regulatory databases like EUDAMED. Their services focus on simplifying the complexities of UDI compliance for medical device manufacturers and distributors.
**Who they are**
udihub.io offers specialized solutions for UDI compliance, focusing on EUDAMED onboarding and data registration support.
**Expertise & scope**
* Automated UDI compliance solutions
* Data centralization for UDI information
* Streamlined UDI submission processes
* Integration with global regulatory databases, including EUDAMED
* UDI Connect Expert Session for detailed guidance
**Who they are**
udihub.io offers specialized solutions for UDI compliance, focusing on EUDAMED onboarding and data registration support.
**Expertise & scope**
* Automated UDI compliance solutions
* Data centralization for UDI information
* Streamlined UDI submission processes
* Integration with global regulatory databases, including EUDAMED
* UDI Connect Expert Session for detailed guidance
Additional information
Engaging with udihub.io for EUDAMED onboarding typically involves leveraging their automated solutions to manage UDI data. Buyers can expect a focus on simplifying the process of centralizing and submitting UDI information to regulatory bodies. The UDI Connect Expert Session is available for direct engagement to address specific compliance needs and integration strategies.
Key Highlights
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Offers automated UDI compliance solutions.
Source
“UDI Hub & UDI Connect offer automated UDI compliance solutions, simplifying data centralization, submission, and global regulatory database integration for EUDAMED.”
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Focuses on EUDAMED onboarding and data registration support.
Source
“UDI Hub & UDI Connect offer automated UDI compliance solutions, simplifying data centralization, submission, and global regulatory database integration for EUDAMED.”
Buyer Snapshot
Best for
- Companies seeking automated UDI compliance
- Businesses needing to centralize UDI data
- Organizations requiring EUDAMED data registration support
How engagement typically works
- Leveraging automated platforms
- Focus on data centralization and submission efficiency
Typical deliverables
- Streamlined UDI data management
- Simplified EUDAMED data submission
- Integration with global regulatory databases
Good to know
- Best when seeking automated solutions for UDI compliance
Languages:
English
Status:
listed
Services & Capabilities
EUDAMED Onboarding & Data Registration Support (Mandatory Modules)
Modules Supported:
UDI/Devices
Submission Approach:
M2M Integration, Bulk Submissions
Portfolio Fit:
100+
Onboarding Speed:
1-2 weeks
Managed Service Available:
Yes
Integration Support:
ERP/PLM mapping
eudamed_m2m
Jurisdictions:
EU
Countries:
DE, FR, GB
Portfolio:
1-5, 6-25, 26-100, 100+
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Additional eudamed_onboarding_support Details
Modules Supported
UDI/Devices, EUDAMED
Submission Approach
Automated data submission
Data Mapping Capability
Implied through data centralization and integration services
Validation Playbook
How validation errors are triaged, documented, and fixed
