2024 Year in Review: UDI Manager and Best Practices

End of the year review: The picture shows a golden 2024 on orange background

We look back on a year of great leaps: Especially in the area of our MedTech solutions, an incredible amount has happened. In addition to numerous improvements to our software, we were also able to support our customers with our newsletter, the integration of new markets, and the implementation of new regulations.

Let´s recap 2024: A new software, an online shop, numerous newsletters, customer meetings, new customers, new markets, regulations, and expansions of our portfolio: We are pleased with a successful year in 2024.

The Introduction of the UDI Manager

Our biggest achievement in 2024 was the development and introduction of our UDI Manager for EUDAMED. In collaboration with our MedTech customers and in exchange with the industry, it became clear to us that a simple, self-service, cost-effective, and flexible way to enter UDIs into EUDAMED was missing. Therefore, this year we focused on developing a largely automated solution alongside our MedTech Enterprise solution. The result is the mytracekey UDI Manager in the Basic, Full, and Full with M2M Connection variants. With these variants, which you can easily book yourself through our online shop, we have created maximum flexibility. At the same time, the software is designed to be so simple that it requires little support, a win-win situation. Our customers get flexible access to a cost-effective tool that helps them solve the otherwise time-consuming and nerve-wracking task of “storing and managing product data in EUDAMED” in the long term.

More International Regulations and New Markets

We have also dealt with numerous regulations, laws, and markets for and with our customers. For example, with post-market surveillance under the EU-MDR or software as a medical device. Of course, artificial intelligence was also a topic at tracekey in 2024. In particular, how we can make our customers’ work easier with AI-supported software solutions. Other topics included e-labeling or the new battery law. New serialization regulations and requirements, such as those in Vietnam, Kazakhstan, TVST, or the MENA states, were also a regular part of our daily routine.

In addition to new solutions for medical device manufacturers, we have worked on additional solutions and support for our pharmaceutical customers. As the serialization requirement in Italy, among other places, is approaching, we are supporting new customers here with our best practices, who have so far only worked with the Bollino system. We have also further expanded our mytracekey Alerts solution and were in constant exchange with our customers on this topic.

We Support Our Customers

In addition to onboarding new business partners, it is very important to us to continuously develop new ideas to best support our pharmaceutical customers and make the implementation of global serialization requirements as easy as possible for them. In addition to our established TKSM services, where various business processes can be outsourced to us, we have also successfully continued our customer newsletter this year. Through this, we support our customers in establishing simpler processes, effectively using new functions of our software, or implementing changes to serialization requirements without any issues.

We are starting the new year with many ideas and projects and look forward to sharing the new developments in 2025 with you.

 

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