osapiens HUB for Medical Devices
Centralize your device data, validate it before errors reach regulatory databases, and syndicate it to every market from a single, trusted source. With osapiens HUB for Medical Devices, you manage UDI data once and use it across all global UDI Databases and commercial databases via GDSN, scaling market opportunities without scaling the workload.
Your products. Multiple regulatory markets. Countless data formats and submission requirements. Why not have it all in one place?
Your medical device data already exists: It just sits across ERP, PLM, PIM systems and Excel files while every regulator expects different fields, structures and submission formats. As a result, you spend time checking requirements manually and fixing errors, while every product change creates another round of updates.
With osapiens HUB for Medical Devices, you bring this data into one versioned, regulator-native record. The HUB validates it against the rules of each target registry, submits it directly to EUDAMED, FDA GUDID, TGA, SwissDamed, and GDSN and keeps every status, change and failure traceable.
From scattered product data to regulator-ready submissions
Ingest product data from every source
Connect ERP, PLM and PIM systems via REST or import Excel files through a guided wizard. Large files are processed in 50-product batches, giving you clear feedback on every created, updated or failed record.
Validate and enrich before submission
Run rule-based checks for each target registry before submitting your device data. Verify MDR and IVDR risk classes, issuer information, and the required GMDN or EMDN classification. Per-row feedback shows what passed, what failed, and where data still needs to be corrected or completed.
Build one versioned device record
Manage Basic UDI-DI, UDI-DI, package and base-item relationships as native data, not flat attributes. Every change creates a new snapshot, giving you a complete history of how each device record evolved.
Submit to every regulator with ease
Use the same governed record to submit to EUDAMED, Swissdamed, AusUDID and FDA GUDID. Submissions are queued, retried automatically and routed into dedicated error queues when something fails.
Disclose every change automatically
Use automated item triggers to send every new or updated device record to the relevant regulatory initiatives. Track a separate status and complete audit history for every regulator, so each disclosure remains visible and traceable.
Frequently asked questions
The osapiens HUB for Medical Devices centralizes medical device product and UDI data in one versioned record. It validates this data against regulator-specific requirements and uses the same record for submissions to multiple global registries.
The HUB supports submission workflows for EUDAMED, Swissdamed, AusUDID and FDA GUDID. Each regulator is connected as a separate submission initiative while using the same underlying device record.
No. You maintain one governed product record and use it across multiple regulatory initiatives. Registry-specific requirements, submission states and histories are managed separately without duplicating the underlying device data.
The data model is built around medical device regulation and submission requirements from commerical databases like GDSN form your customers and trading partners. Basic UDI-DI and UDI-DI hierarchies, package relationships, MDR and IVDR risk classes, GMDN and EMDN codes and issuer matching are native parts of the record rather than generic fields added later.
Rule-based checks validate each record against relevant regulatory requirements before it enters a submission lane. Teams receive detailed feedback on missing, invalid or inconsistent data and can correct issues before they reach the regulator.
Failures are sorted by their actual cause, including request, authentication, network, response, parsing and generation issues. Dedicated error queues help teams resolve the root cause and resubmit instead of tracing individual message IDs.
Every product change creates a versioned snapshot. The HUB keeps the full history of the device record together with the validation results, submission states and regulatory actions connected to it.
Product data can be ingested from ERP, PLM and PIM systems, REST interfaces or Excel files. External systems and stakeholders can connect through scoped REST APIs, while role-based access and Enterprise SSO control who can access which functions and data.
A central dashboard brings together device data, validation results, submission statuses and unresolved issues across product lines and regulatory initiatives. This helps your teams see where action is needed without checking separate systems or individual submissions.
EUDAMED Compliance Made Simple – Your Guide to Successful Implementation
Get to grips with EUDAMED, from the obligations on economic operators to UDI and device registration. This guide breaks the requirements into a clear implementation path, and shows how the right digital tools cut manual effort and keep your data accurate and consistent across systems.
