- Hardware and Software solution for 2D code verification according to ISO/IEC TR 29158 (AIM DPM) -
"Do not wait any longer, react now!"
The call for a globally uniform system for the identification of medical devices by the American FDA and the European MDR is increasingly leading to a significant change of requirements within the medical technology industry.
Besides a multitude of factors to be considered in the context of these regulations, the marking of products such as implants, surgical instruments etc. plays a central role.
The so-called UDI codes must be unique and permanently legible. The code structure is designed in two parts and has a clear text part that can be identified by the human eye and a machine-readable part, e.g. data matrix code.
In terms of a valid marking process the mere application of the UDI marking is not sufficient. Taking a holistic approach into account, the WHB UDI Marking System was developed especially for medical technology companies. The optimally coordinated combination of camera system and PC application ensures the accompanying verification of the marking result according to ISO/IEC TR 29158 (AIM DPM) and massively exceeds the customer benefit compared to a mere production-accompanying, camera-based validation in the marking process. Process validation is also supported by database-supported record keeping and detailed quality reports. Interfaces to common ERP and laser systems make the application universally applicable and manufacturer-neutral. The WHB UDI Marking-System thus excludes errors in the marking process and supports the documentation and archiving of the marking result.
Further, detailed information about our WHB UDI Marking-System can be found here.
In order to meet the different customer requirements in our market environment, a reduced version, the WHB UDI Verify Standard, is also available in addition to the WHB UDI Marking-System. The Verify standard is suitable for customers for whom the connection to an ERP system or the marking laser is initially undesirable. The Verify Standard can be extended at any time afterwards to a Marking-System and thus to a system with a holistic approach including order entry and data reconciliation.
A comparison of the core features of both versions can be found here.