Reliable MDR and FDA Compliance for Medical Devices with COSMO ERP Unique Device Identification
Central UDI master data management, GS1-compliant labeling, and ready-to-use exports for the EUDAMED and GUDID databases — directly in Microsoft Dynamics 365 Business Central.
Regulatory confidence (MDR / FDA) in your ERP—UDI management, labeling & compliant data exports
COSMO ERP Unique Device Identification is a streamlined extension for Microsoft Dynamics 365 Business Central that helps you meet the requirements of the Medical Device Regulation (MDR) and the FDA. The solution consolidates all UDI-relevant master data at item and variant level, provides contextual validation checks, and generates standardized datasets for exports to regulatory data platforms in the EU and the US.
You also benefit in daily operations: create GS1- or HIBC-compliant UDI labels, track print jobs, and generate XML exports for the GUDID and EUDAMED databases — all directly within the system. This reduces manual tasks, eliminates duplicate data maintenance, and improves audit readiness. With preconfigured data packages, COSMO ERP Unique Device Identification is quick to implement—delivering measurable value fast.
How COSMO ERP Unique Device Identification solves your biggest challenges
Features - What's Under the Hood
Central UDI Master Data Management
Manage Basic UDI, Device Identifier (DI), Product Identifier (PI), brand names, packaging hierarchies, and product attributes directly in Microsoft Dynamics 365 Business Central.
Separate Entry Screens for EU (MDR, IVDR) and US (FDA)
Separate Entry Screens for EU (MDR, IVDR) and US (FDA)
Mandatory Fields and Validation Rules
Configurable validation ensures data quality during entry, reducing corrections later during exports.
Audit Trail and Permission Management
Complete change logs with history and approval workflows support compliance and audit preparation.
GS1- and HIBC-Compliant Labeling, plus NiceLabel Integration
Preconfigured print data for GS1-128 and DataMatrix codes, optional integration with NiceLabel, and print logging with reprint options.
XML Data Export for GUDID and EUDAMED
Standardized XML exports reduce upload errors and simplify regulatory submissions.
Seamless Integration into Microsoft Dynamics 365 Business Central
End-to-end processing in the ERP minimizes integration effort, prevents duplicate data, and ensures compliant workflows from production to shipping.
Take a look—this is how the system works in practice
Device Identification data (DI) for EU MDR/IVDR in Microsoft Dynamics 365 Business Central
Fully integrated with Microsoft Dynamics 365 Business Central
Your UDI processes belong where they deliver the most value: directly in your ERP. COSMO ERP Unique Device Identification integrates seamlessly with Microsoft Dynamics 365 Business Central, enabling an end-to-end data flow without media disruptions.
All product master data, UDI attributes, and labeling information remain centralized in the ERP, so purchasing, production, quality, warehouse, and service teams work with the same validated data.
This reduces duplicate entry, streamlines workflows, and accelerates day‑to‑day decision‑making. With preconfigured data packages and standardized export formats, you achieve fast time-to-value and avoid custom development. Before going live, we recommend stability checks of the print interfaces and validation of XML exports.
COSMO CONSULT—Your partner for a secure UDI solution
With COSMO CONSULT, you get more than an implementation partner. We guide you from initial analysis to stable operations—structured, practical, and backed by deep ERP and MedTech experience.
We start by reviewing your processes together and defining the foundation for a tailored implementation. We install and configure the solution, migrate your data, and train your team. Preconfigured data packages enable a fast and secure rollout.
We support you throughout testing and assist with integrations such as NiceLabel (Loftware). And after go-live, we stay by your side—with training, support, and continuous optimization, ensuring your team works confidently and sees value quickly.
The result: a UDI implementation that is fully compliant and fits seamlessly into your daily workflows.
11
customers use the cloud-based SaaS version
Ø 45
users per installation
Recent Awards
6x Microsoft Solutions Partner
Awarded Microsoft's highest quality seal in all categories.
Microsoft Dynamics Inner Circle
Ranked among the top 1% of partners worldwide every year since 2014.
Top-Arbeitgeber
Ranked among the top 0.4% of all employers in Germany.
BARC-Studie 2026
Leading Data & Analytics Partner: 11× Leader, multiple #1 rankings, and a 100% recommendation rate.
Our software is already being used successfully by these companies
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