Product Overview

COSMO Unique Device Identification (UDI) empowers medical device manufacturers to comply with FDA and EU UDI regulations efficiently. This solution ensures clear identification and traceability of medical devices throughout their lifecycle by linking item master data with UDI properties. Users can print UDI labels directly from production and upload necessary data to GUDID or EUDAMED via structured XML files. Integrated within Microsoft Dynamics 365, COSMO UDI streamlines compliance, saving time and costs while eliminating the need for additional UDI applications.

Main Features

• Compliance with UDI Regulations
• Integrated UDI Solution
• Dynamic Product Information Management
• User-Friendly UDI Label Printing
• Data Upload to Regulatory Databases
• Comprehensive UDI Data Management

Why choose COSMO Process Manufacturing CRM?

• Stay compliant with FDA and EU UDI requirements: You ensure adherence to regulatory standards, minimizing legal risks and enhancing product credibility.
• Link item master data with UDI properties: You achieve streamlined data management, improving accuracy and efficiency in tracking medical devices.
• Print UDI labels directly from production: You enhance operational efficiency by integrating labeling into your production workflow, saving time and resources.

Supported Countries

Germany, Austria, Switzerland, United States, United Kingdom, Australia

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

Supported Languages

German (Austria), German (Switzerland), German (Germany), English (United Kingdom), English (United States)