Blog title heading will go here

Anja: EUDAMED is recognized as one of the most detailed regulatory systems worldwide, and its approach to the parent-child UDI-DI hierarchy adds significant complexity. Manufacturers must accurately manage and map hundreds of data elements for both parent (Basic UDI-DI) and child (UDI-DI) devices. This mapping must conform to more than 300 EUDAMED-specific validation rules, as well as additional requirements for other markets.

Maintaining precise relationships between Basic UDI-DIs and their child UDI-DIs is critical. Any inconsistency - such as a mismatch in attributes or relationships - can lead to rejected submissions and delays. Furthermore, EUDAMED’s API is technical in nature and does not provide use-case guidance, requiring manufacturers to interpret and implement rules themselves. Without specialized tools, these requirements can quickly become overwhelming for regulatory teams.

Przemysław: UDI Hub is designed to address these exact challenges. The solution offers intuitive workflows that guide users through the process of creating, mapping, and maintaining parent-child UDI-DI relationships, consolidating all data into a centralized system.

Automation within UDI Hub covers over 90% of EUDAMED’s validation rules. When users enter data, the system checks for errors, missing fields, and inconsistencies, ensuring accuracy before submission. Visual hierarchy mapping makes device relationships clear and reduces the risk of mistakes, enabling regulatory teams to concentrate on higher-value activities.

Anja: Certainly. One mid-sized medtech company with over 500 devices previously struggled with manual management of parent-child UDI-DI relationships, resulting in frequent submission errors and delays. After implementing UDI Hub, the company saw a 50% reduction in time spent on data validation and submission, and an 80% decrease in submission errors. This not only saved time but also lowered compliance costs, allowing the regulatory team to focus on strategic work.

Przemysław: Yes. UDI Hub provides detailed error notifications so users can identify and resolve issues quickly.

The solution also allows users to retry submissions after correcting data. There is no need to start over- the system remembers the previously approved state of the dataset. This is an especially valuable feature for companies managing large device portfolios.

Anja: We actively monitor changes in regulations, including EUDAMED, and update UDI Hub accordingly. When new validation rules are introduced, we ensure the platform reflects those changes, so customers can remain compliant without workflow disruption. This proactive approach gives users confidence that their compliance processes are always aligned with current standards.

Przemysław: UDI Hub’s API-first architecture supports integration with ERP, PLM, and other data management systems, ensuring real-time data synchronization and consistency. We provide comprehensive documentation and expert support to make the integration process straightforward, whether companies use SAP, other ERP systems, or custom-built solutions.

Anja: The greatest benefit is peace of mind. UDI Hub reduces manual work, minimizes errors, and ensures data accuracy for submission. Whether you’re a small medtech business or a large enterprise, UDI Hub offers a scalable, reliable solution that saves time and supports confident compliance.