Enables Medical Device manufactures to cover the UDI requirements of the FDA and the EU

Unique Device Identification - or "UDI" for short - has been mandatory for manufacturers of medical devices since the European Medical Device Regulation (MDR) came into force. In some countries, such as the USA, the UDI system has already been mandatory for several years. An important goal of UDI is the clear identifiability and traceability of medical devices along their entire product life cycle.

The UDI requirements determine, that medical devices worldwide must have a unique Device number (device identifier), which can be identified by barcode or DataMatrix on the product itself or on its outer packaging or printed on its outer packaging. In addition dynamic product information (product identifier) such as the serial / lot number, the expiry date or the date of manufacture.

COSMO UDI supports you with a comprehensive range of user-friendly tools, meet the requirements of the new labeling regulations.

With COSMO UDI ...

You stay complaint with the FDA and EU UDI Requirements
You link the Item master data with all UDI relevant properties
You are able to print UDI labels directly from the production process
You are able to upload the necessary UDI information into GUDID or EUDAMED Database via structured XML Files
You don´t need any other UDI Applications
You have a fully ERP integrated UDI Solution
You spare costs and time

UDI Datamanagement / Attributes

COSMO UDI provides you with separate acquisition pages for the required FDA information as well as for the EU information. All master data and UDI attributes can be conveniently entered here. Seamless integration in Microsoft Dynamics 365 Business Central makes it easy to maintain data at item model level and item variant level. For the management of the basic UDI data, the user is provided with an own acquisition page at item model level. The input of this data is conveniently supported by the system. These system functions include mandatory field and plausibility checks as well as context-related checks.

Data Release and Audit Trail

With a configurable authorization management, data releases can be handled flexibly. The change log functionality included in Microsoft Dynamics 365 Business Central provides the necessary audit trail and makes the change history available at any time at the push of a button.

Labeling Support

COSMO UDI supports the printing of a standard UDI label based on GS1 standards. In addition to the DI + PI elements, further information is displayed on the label (e.g. product properties, manufacturer information, brand names, nomenclatures, etc.). All symbols and product properties are stored in Business Central. Every print activity is accurately logged and stored with all print data, so that reprints are possible at any time. For easy connection to an external label printing solution, COSMO UDI provides an interface in which the print data is already collected and prepared for transfer. This data can be exported to any third-party system.

Data Export

The 3rd pillar of the UDI system is the data exchange or data upload into the central databases GUDID (FDA) and EUDAMED (EU). COSMO UDI provides an XML data export for this purpose, which follows the specifications of the respective authorities.

Supported Editions

This app supports the Essential and Premium editions of Dynamics 365 Business Central.

Supported Countries

Austria, Australia, Canada, Chile, Colombia, France, Germany, Hong Kong SAR, Hungary, Latvia, Peru, Romania, Spain, Sweden, Switzerland, United Kingdom, United States

Country availability is technically verified. Please contact us for country specifics of features.

Supported Languages

German (Germany), English (United States), French (France), Swedish (Sweden)

COSMO Unique Device Identification

avtor: COSMO CONSULT