Monitoring systems for medtech

For producers of medical devices and manufacturers operating in environments where pharmaceutical goods and medtech equipment are produced an efficient monitoring system is very important, since manufacturers have to prove that they have a quality management system in place and they must also demonstrate that the medical devices they produce meet the requirements for safety and quality. Kistler meets their need with the latest version of maXYmos system; maXYmos TL ML can easily be qualified and validated for integration into existing quality management systems.

Thanks to the new maXYmos TL ML process monitoring system from Kistler, producers of medical devices as well as machinery and plant manufacturers operating in the medtech and pharmaceutical sectors will now find it much easier to validate their production processes. In the best-case scenario, 100% inspection of a manufacturing step can eliminate the need for mandatory process validation in production.

Monitoring every manufacturing step

Like all the systems in the maXYmos family, maXYmos TL ML visualizes process profiles and offers an extensive range of interfaces for connecting sensors. The system is integrated directly into the production line to monitor and evaluate the quality of any given manufacturing step – and therefore of the whole product – on the basis of a curve. With the help of evaluation objects, users can adapt the curve evaluation to the specific monitoring task. For instance, the tolerances defined in the process validation can be used for this purpose. Based on this specification, the system then decides whether each workpiece is good or bad.

The functions integrated in maXYmos TL ML comply with the regulatory requirements for applications in the medtech industry. maXYmos TL ML supports OPC UA, so it can easily be connected to machine controls and can communicate with higher-level control and management systems. This new process monitoring system from Kistler has FDA and MDR-compliant functionalities.