FDA and MDR compliant process monitoring system for medical device assembly and testing

maXYmos TL ML the product monitoring system for medical device production meets the requirements of manufacturers of medical devices as well as plant and machinery manufacturers operating in environments where pharmaceutical goods and medtech equipment are produced or assembled and tested: this monitoring system can deliver 100 percent testing. It is the first process monitoring system that meets the strict regulatory requirements for quality assurance in the medtech sector.

Our maXYmos system is used for automated monitoring and analysis of processes, in keeping with Industry 4.0 requirements. The focus is on automated segregation of scrap parts, based on pressure, force and torque – always with the goal of ­zero-defect production in mind.

Having joined forces with partners in the mechanical engineering and plant construction industry, we developed the maXYmos TL ML process monitoring system, in strict compliance with the guidelines of the FDA (U.S. Food and Drug Administration) and the MDR (Medical Device Reporting regulations. Therefore, 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

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.

• Monitoring process stability
• Automated detection of process deviations, including notifications to the user
• Transparent process control and production monitoring during qualification (OQ and PQ)
• Fieldbus communication to transfer part-specific process data to external databases for documentation purposes
• Static process analysis of data with part-specific attributes

Thanks to our new maXYmos TL ML process monitoring system, you as 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 your 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. We are support you particularly by supplying:

• Ready-to-use checklists for Installation Qualification (IQ)
• Ready-to-use checklists for Operational Qualification (OQ)
• An in-plant calibration – this will make requalification of assembly plants much simpler, as we calibrate the entire measuring chain

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.

Force, pressure, acceleration and torque represent direct criteria for determining the production quality of medical devices, during manufacture and in testing processes. In addition to the machine data, these measurands play a key part in transparent process monitoring. To achieve this objective, Kistler offers you an extensive range of high-precision sensors.

We will efficiently support you in achieving a MDR and FDA compliant quality assurance for medical device manufacturing and the production of pharmaceutical products.
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• Zero-defect production
• Compliance with all standards and regulations
• Seamless (IQ/OQ) documentation
• Integrated user management and audit trail, meeting FDA and MDR requirements
• Reduced quality costs
• Rapid amortization (RoI)