Winterthur, December 2022 – An update to the process monitoring system maXYmos TL ML from Kistler is now available worldwide. The new version 1.8 allows medical device manufacturers and plant builders in the sector to further simplify user management and increase measuring accuracy. Launched in 2020, the maXYmos TL ML is the first system to enable effective process monitoring that is compliant with FDA and MDR regulations. The update maintains this regulatory compliance and other proven features while offering additional advantages such as the new sensitivity correction functionality, the improved audit trail function and a master administration system.
Like few other industries, the medtech sector is subject to strict regulations, with high requirements for product safety, quality management and process validation. The introduction of the world’s first FDA- and MDR-compliant process monitoring system thus met an urgent need of machine and plant builders as well as manufacturers in the medtech industry: maXYmos TL ML is used all over the world to improve the production quality of medical devices during joining and assembly processes and in testing procedures. In addition, its new features, such as the new sensitivity correction functionality, the improved audit trail function and a master administration system render it useful for other industries as well. Especially in sectors that depend on precise measurements, reproducible processes and full traceability, the system can prove its advantages.