KMC Medical Manufacturing Quality Assurance

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. 

Robust Medical Device Quality Management

Our robust Quality Management System (QMS) ensures compliance with FDA Quality Systems Regulation 21 CFR Parts 820, 803 and 806 as well as ISO 13485. This customized system includes step-by-step visual instructions and our own quality assurance processes for consistently reliable 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.