EUDAMED is now mandatory. The challenge is keeping your data under control.
Since 28 May 2026, the modules for actors, UDI/devices, notified bodies and certificates, and market surveillance have become mandatory. For many manufacturers, the work doesn’t end with the first registration: incomplete information must be corrected, historical portfolios resolved, new entries and changes processed, and internal systems kept aligned with EUDAMED.
When the portfolio grows, working record by record or maintaining multiple spreadsheets leads to costs, errors and poor traceability. Offing turns that process into a controlled technical workflow: we import or connect the source, validate, generate the required structures, manage responses and leave evidence of every step.
Are you in any of these situations?
You have thousands of devices to register and keep up to date.
Your information is spread across ERP, PIM, QMS, documents and Excel sheets.
You need to generate XML files compatible with EUDAMED’s official schema.
You’re looking for a solution that also supports recurring creations and updates.
From scattered data to a verifiable submission process
We create a layer between your systems and EUDAMED — an end‑to‑end flow where every step is controlled and traceable.
The right level of automation depends on your volume and frequency
We don’t recommend developing software when the cost of automation exceeds the real operational cost. We choose the proportionate path for your case.
Manual upload
Digitise a specific internal process, automate administrative tasks or create a simple private portal for clients or suppliers.
Bulk XML upload
For medium volumes or an initial migration, we import your data, validate it and generate the required XML files. Uploads are done through the interface, while repetitive work and error detection are automated. Indicative: 100–1,000.
M2M-DTX exchange
For large portfolios, frequent changes or corporate integration, we connect your system to the M2M exchange through an AS4-compatible Access Point. Indicative: +1,000.
Qué podemos desarrollar para tu organización
A phased project with verifiable decisions
Technical and regulatory discovery
We bring together Regulatory Affairs, QA, IT and operations. We identify actors, scope, device types, sources, volume, frequency and responsibilities.
Mapping and rules
We define the correspondence between the source and EUDAMED, transformations, validations and criteria that require client approval.
Testing and correction
We validate batches, process responses and adjust rules with real data. For M2M, we complete testing and onboarding with the Access Point.
Support and evolution
We manage incidents, version changes and new needs with an ongoing service.
Sampling and profiling
We work with a real sample. We measure completeness, duplicates, formats and dependencies before closing scope and pricing.
Flow development
We build import/connectors, staging, validations, generation and the monitoring panel.
Production deployment
We execute the migration or activate synchronization, generating evidence and a results report.
A solution tailored to your needs, not a suite you must adapt
Some companies need a global regulatory platform. Others need to solve EUDAMED without taking on licences, processes and modules they won’t use. Offing evaluates both options honestly. When a custom solution adds value, we design only the necessary capabilities and connect them with your current ecosystem.
Technical control for a sensitive process
Role‑based access and the principle of least privilege.
Logging of actions and changes.
Separate testing and production environments.
Secure management of credentials and secrets.
Backups, monitoring and incident logging.
Version control for rules, schemas and deployments.
EUDAMED connected to the system that already governs your data
We work with REST, SOAP, GraphQL, files, queues and batch processes, and we develop backend in Python and modern web applications for operational management.
FAQ
What they usually ask us
Tell us how you manage your EUDAMED data today
In an initial conversation we review your device volume, sources, change frequency and the current state of your uploads. We’ll clearly tell you whether you need a tool, an XML upload, an M2M integration or simply improving the existing process.