KMC Systems produces world-class medical devices and instrumentation by employing an integrated manufacturing execution system (MES) and quality management system (QMS). KMC's proprietary, FDA-compliant, automated software that is customized specifically for medical applications for greater adherance to specific regulatory requirements. Coupled with our proven processes, our MES enables rapid start-up of new projects, strengthens quality control, and manages documentation for traceability and regulatory compliance.
Additional benefits of our medical device manufacturing execution system include:
Robust Medical Device Quality Management
Our manufacturing execution system includes step-by-step visual instructions and our own quality management system for greater assurance of excellent quality and workmanship. Each specially trained test technician must follow each precise step in order to proceed through the guided system. Alerts notify technicians and our Quality Assurance department of any out-of-tolerance data, allowing us to take immediate action.
Medical Manufacturing Regulatory Compliance
KMC Systems’ manufacturing execution system also manages documentation for traceability and regulatory compliance, storing all necessary data (including device history records, reports on calibration procedures and test data) for more seamless FDA inspections and ISO 13485 audits.
Rapid and Precise Execution
Our software platform is customized for each project and provides step-by-step, visual instructions. The detailed, picture-based instructions reduce assembly and test time, helping customers be quicker and more responsive to market demands.
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