FDA- and MDR-Compliant Process Monitoring for Medtech Industry

maXYmos TL ML from Kistler (Winterthur, Switzerland) is the first process monitoring system that meets the strict regulatory requirements for quality assurance in the medtech sector.

A monitoring system that can deliver 100 percent testing: This is a critical requirement for producers of medical devices as well as plant and machinery manufacturers operating in environments where pharmaceutical goods and medtech equipment are produced. Kistler now meets this need with the latest version of its maXYmos system. maXYmos TL ML can easily be qualified and validated for integration into existing quality management systems.

Process monitoring systems play an increasingly important part in quality assurance on automated production lines for medtech devices. Medical device manufacturers not only have to prove they have a quality management system in place; they must also demonstrate that the medical devices they produce meet the requirements for safety and quality. Their further obligations include providing proof of 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.

Confronting Liability

In extreme 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 their products fail to function perfectly. This is partly why the industry is subject to such strict regulation. 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 these obstacles, 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 its Medical Device Reporting (MDR) regulations.

FDA- and MDR-Compliant Functionalities

Kistler has developed this new solution on the basis of its maXYmos TL (Top Level) system. Like all the systems in the maXYmos family, maXYmos TL 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 (EOs), 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. The system hardware also meets the specific requirements for measurement equipment that apply in the medtech industry, including:

• Design to accommodate exceptionally small measuring ranges (force-displacement monitoring, torque sensor technology)
• Integrated user management compliant with FDA regulatory requirements
• Audit trail: recording and monitoring of all changes to testing processes, with time and user indexing for end-to-end traceability of each individual product
• Optional blocking of ports for secure integration into the customer’s data structure
• Direct printer connection so that test records can also be documented as hard copies
• Optimized production processes give medical device manufacturers competitive edge

Thanks to the maXYmos TL ML process monitoring system, 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 percent inspection of a manufacturing step can completely eliminate the need for mandatory process validation in production.

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 – a service that Kistler offers for its customers throughout the world. This also makes requalification of assembly plants much simpler, because the entire measuring chain is calibrated. The key benefit: manufacturers can bring their product developments and innovations to market much more quickly – giving them the competitive edge that is such a critical factor in this industry.

Into the Future with Intelligent Networking and Control

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.

www.kistler.com