KMC Systems produces superior medical devices and instrumentation by employing an integrated manufacturing execution system (MES). Our proprietary, FDA-compliant, automated software is customized specifically for medical applications, adhering to specific regulatory requirements. Coupled with our process management techniques, our MES enables rapid start-up of new projects, strengthens quality control, and manages documentation for traceability and regulatory compliance.
We recognize that our customers bet their brands on us. Our manufacturing execution system assures that we don’t disappoint.
Additional benefits of our manufacturing execution system include:
- Rapid Ramp-Up
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.
- Rigorous Quality Control
Our trained test technicians follow the manufacturing execution system’s step-by-step visual instructions, providing greater assurance of quality and workmanship. Alerts notify technicians and our Quality Assurance department of out-of-tolerance data, allowing us to take immediate action.
- 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.
- Customer Access
Our MES provides customers with web-based access to manufacturing reports as well as parts and shipment tracking.