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Anja: EUDAMED is one of the most comprehensive regulatory systems globally. For each device, manufacturers must manage 208 data elements and comply with 300–400 validation rules to ensure data accuracy before submission. This complexity is further amplified when considering compliance across all regulatory authorities, where the number of rules can reach 1,000–2,000.

The submission process itself is also demanding. It requires technical data
exchanges, regular updates, and compliance with market-specific requirements. Each phase introduces potential for errors, which can delay approvals or result in rejections.

Moreover, EUDAMED’s APIs are designed for technical users and lack use-case guidance. Developers must manage the detailed technical implementation independently, which requires significant expertise. Without suitable tools, these requirements can quickly become overwhelming.

Anja: These solutions help manage regulatory requirements by automating validation, submission, and monitoring workflows. UDI Connect and UDI Hub break down the complexity of EUDAMED into manageable parts, reducing the compliance burden.

For instance, our solution is designed to handle over 90% of EUDAMED’s validation rules. While not every rule can be implemented due to variations in regulatory interpretation, the software covers the most critical aspects, significantly reducing error rates and submission rejections.

Additionally, we focus on the full compliance process - not just on providing APIs. The solutions offer feedback and guide users step-by-step, reducing complexity and allowing teams to focus on their core business instead of regulatory details.

Our experience with enterprise customers has been distilled into these solutions, making robust compliance processes accessible for smaller med-tech companies as well.

Anja: Certainly. For a single device, manual data entry and validation can take hours. With automation, our customers report saving up to 50% of the time previously spent on validation and submission.

For larger portfolios, the impact is even greater. One customer with over 500 devices reduced submission errors by more than 80% through automated validation and error-checking in our solutions.

This reduction in manual effort and errors translates directly to time and cost savings.

Anja: Regulatory requirements are always evolving. We monitor global changes - including EUDAMED - and update the system to reflect new requirements.

When new validation rules are introduced, these are incorporated into the solutions, allowing teams to adapt without workflow disruption. This proactive approach helps users stay ready for audits and regulatory changes.

While we can’t always predict regulatory timelines, regular updates and a scalable infrastructure allow us to add new market requirements efficiently.

Anja: The API-first architecture of our solutions supports integration with ERP
systems as well as PLM and custom data management systems. This enables real-time UDI data synchronization and consistency across platforms.

We provide comprehensive documentation, sample payloads, and expert support to facilitate integration, whether for standard or custom IT environments.

Anja: The main benefit is confidence in compliance. EUDAMED’s requirements are complex, but these solutions reduce manual work, minimize errors, and help ensure that data is accurate and ready for submission.

By managing the details of compliance, we allow teams - whether from small
companies or global enterprises - to save time, reduce costs, and stay compliant with regulatory requirements.