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When implementing a UDI marking solution for medical products, the acquisition of suitable technology is only the first step. It becomes more complex when the system, the marking software, the exact process sequence and the final marking quality need to be secured and validated. This also includes comprehensive documentation and transmission to the official databases in accordance with the MDR/FDA specifications for unique product identification.
In the Expert Talk, Christian Söhner, FOBA's Global Vertical Manager Medical, and Wolfgang Hirschauer, Validation Consultant at MEDAGENT GmbH, will explain what needs to be considered for validation in compliance with regulations.
You'll learn...
- which steps are part of a validation process
- what time frame you should plan with
- what role an IQ-OQ-PQ-MQ plays
- how to simplify the validation process
Fill out the form and get access to the webinar and additional documents.
Reliable lasers that reliably mark countless materials are available from us: Our CO2 and fiber lasers (Yb) as well as Nd:YAG, vanadate (Nd:YVO4) and UV lasers mark not only metals, plastics, ceramics, glass, papers and woods, but also exotics such as food or textiles. Laser marking devices from FOBA are used in almost all industries worldwide.
FOBA laser markers offer many accessories and options for individual configurations and for optimal integration into existing processes.
Four wavelength ranges
Focusing optics
Vision systems
Axes, rotary tables, cross tables
Customized software solutions
Beam deflection units
Languages for worldwide users
Extraction systems
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"Especially in the area of quality, FOBA fulfills our needs better than many other providers. In close cooperation with FOBA's laser marking experts, we set up the appropriate technical environment that allows us to comply with the high implementation requirements of UDI-marking on medical instruments. For us, the camera based marking validation being integrated in our production process is essential."
Nermin Duratovic, CEO - add'n solutions GmbH & Co. KG
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