New process monitoring system for medical technology: quality assurance compliant with FDA and MDR criteria

Winterthur, October 2020 – maXYmos TL ML from Kistler is the world's first process monitoring system that meets the strict requirements for quality assurance in the medtech industry. Thanks to the latest version of the tried-and-tested maXYmos from Kistler, medical device producers as well as manufacturers of plant and machinery for this sector can now integrate a standard-compliant system for 100 percent inspection.

Process monitoring systems play an increasingly important part in quality assurance on automated production lines for medtech devices. As well as having quality management systems in place, medical device manufacturers must also be able to prove that their products meet the safety and quality requirements. They have to provide proof of suitable quality assurance for all their machines, tools and the entire manufacturing process. And as yet another requirement, medical device manufacturers have to verify their suppliers' quality management systems.

Simplified qualification and validation ensure that liability is excluded

In serious cases, inadequate quality assurance during the production of medical devices can put people in harm's way or even lead to loss of life. Companies that place medical devices on the market are fully liable in the event that their products fail to function perfectly – which is why the sector is subject to such strict regulation. This means that producers of medical devices as well as plant and machinery manufacturers operating in the medtech and pharmaceutical sectors are confronted with huge challenges – especially when it comes to integrating process monitoring systems into automated production and packing processes.

To help customers overcome the obstacles they face, Kistler has joined forces with partners in the mechanical engineering and plant construction industry to develop the maXYmos TL ML process monitoring system, in strict compliance with the guidelines of the FDA (U.S. Food and Drug Administration) and the European Medical Device Regulation (MDR).

A process monitoring system with FDA- and MDR-compliant functions

Kistler has developed this new solution on the basis of its tried-and-tested maXYmos TL (Top Level) system, which is already in widespread use throughout industry. Like all the systems in the maXYmos series, the TL ML version visualizes process profiles on the basis of data from sensors – with the option of connecting large numbers of different sensors via extensive interfaces. maXYmos TL ML is integrated directly in the production line to monitor and evaluate the quality of a production step – and, therefore, of the manufactured product – on the basis of the profile for two selectable variables, X and Y. With the help of evaluation objects (EOs), the assessment of the curves can be adapted to the specific monitoring task – using the tolerances defined in the process validation, for instance. In accordance with this specification, the system decides whether each workpiece meets the defined criteria; bad parts are separated out automatically.

The functions integrated in maXYmos TL ML comply with the regulatory provisions for applications in the medtech industry. The system hardware also meets the specific requirements for measurement equipment that apply in the medtech industry, including:

• Design to cope with exceptionally small measurands (such as forces or torques)
• Integrated user management compliant with FDA regulations
• Audit trail: all changes to testing processes are recorded with a time and user index for end-to-end traceability of every single product
• Secured, switchable ports for integration into the customer's production environment
• Direct printer connection so that test records can also be documented as hard copies

The new maXYmos TL ML also supports OPC UA, so it can easily be connected to machine controls and can communicate efficiently with higher-level control and management systems.

Optimized manufacturing processes for medical devices

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 plants and production processes. In the best-case scenario, 100 percent inspection of a manufacturing step can completely eliminate the need for mandatory process validation in production.

In most cases, qualification of the production equipment is the first requirement for proof of the system's safety. For this purpose, Kistler supplies ready-to-use checklists for Installation Qualification (IQ) and Operational Qualification (OQ). An in-plant calibration can then be performed to validate the measurement system at any time. Kistler offers this service for its customers throughout the world. This also makes production requalification much simpler, because the entire measuring chain is calibrated. The key benefit: manufacturers can bring their product developments and innovations to market more quickly – giving them the competitive edge that is such a critical factor in this industry.