Manage UDIs efficiently, flexibly and independently

The Medical Device Regulation (MDR) is one of the most complex regulations in the world and presents medical device manufacturers with major hurdles. Medical technology companies therefore need a validated system that is suitable for everyday use and enables them to meet the challenge of UDI management and reporting to EUDAMED independently and cost-effectively.

We believe that a flexible and cost-effective tool is currently lacking on the market. Therefore, our aim with the mytracekey UDI Manager is to offer manufacturers of medical devices the opportunity to organize their UDI management independently, efficiently, and at a fair price. Accordingly, we have developed the mytracekey UDI Manager as an additional solution in close cooperation with our mytracekey MedTech Enterprise customers. Thanks to our innovative technological approach, many process steps have been automated so we can now offer our software to all companies with up to 3,000 UDIs at an unbeatable price. Companies with a higher UDI volume benefit from a customized offer for our enterprise solution.

Early Access Phase: Get all the benefits for €99 /month

With our mytracekey UDI Manager, you can manage your UDI data, including all requirements according to MDR, MDD, IVDR, and IVDD, in a structured and clear manner. You have the option of conveniently importing your UDI data into our software with an Excel file, which facilitates the transfer and integration of existing data. You can also check your UDI data for completeness by using the EUDAMED Business Rule Checks to ensure that all required information is correct and complete. You are able to transfer your data to EUDAMED as an XML file or via an M2M connection, providing a smooth and efficient data transfer. Additionally, you benefit from a comprehensive documentation package that includes validation documents and training material to help you implement our software yourself.

Early Access Package

  • Data management: Manage your UDI data, including all templates (MDR, MDD, IVDR, IVDD)
  • Data import: Import your UDI data as an Excel file
  • Data check: Check your UDI data for completeness (EUDAMED Business Rule Checks)
  • Data transfer: Data transfer to EUDAMED (XML file or M2M connection)
  • Onboarding: Comprehensive documentation package, incl. training material

Benefits at a glance

  • A unique storage location replaces manual processes and Excel sheets
  • The software is designed so that you can carry out both onboarding and use on your own, but if you have any questions, our support is of course available to you
  • Unnecessary product recalls due to incorrect or inconsistent data are prevented
  • You manage your product data in compliance with the MDR from the beginning

Flexible subscription model

Benefit from the comprehensive flexibility of our subscription model: you decide for yourself how long you want to use the UDI Manager. This allows you to enjoy the benefits of effective UDI management and EUDAMED reporting regardless of long contract periods. The UDI Manager continuously supports you in keeping your data in EUDAMED up to date.
Simply secure our early access offer by registering.