- May 27, 2020
- Kistler Instrument Corporation
May 27, 2020 - maXYmos TL ML from Kistler is a process monitoring system that meets the strict regulatory requirements for quality assurance in the medtech sector. maXYmos TL ML can be qualified and validated for integration into existing quality management systems.
Process monitoring systems play a part in quality assurance on automated production lines for medtech devices. Medical device manufacturers have to prove that 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.
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 its Medical Device Reporting (MDR) regulations.
Kistler has developed this 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 a 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
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.
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.
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