Consulting on UDI marking

Unique and traceable labeling of medical devices is one of the obligations of manufacturers. By means of Unique Device Identification (UDI), a system for the identification, labeling and registration of medical devices and in vitro diagnostics has been developed. 

The aim is to increase patient safety through the complete traceability of products. The way or process to this identification is implemented in cooperation with UDI allocation bodies such as GS1 (https://www.gs1.at/udi). 

However, not only the one-time allocation of this product identification can already be challenging but also the proper application on the products as well as a traceability in case of changes to the medical devices.

We are happy to advise and accompany you on your way to work out standardized procedures for the following areas:

• the correct product identification
• the error-free labeling of your medical devices
• the merging of the required product data
• the transmission of new and modified product data to business partners and authorities