KMC Systems Medical Contract Manufacturing

Since its inception in 1980, KIMC Systems has been successfully manufacturing high-value, complex platforms for use in highly-regulated environments. Our Manufacturing Execution System (MES) has evolved from decades of regulatory audits and is combined with strict process controls, lean manufacturing methods and a robust Quality Management System (QMS).

  •         ISO13485:2003
  •         GMP compliant
  •         BioSafety laboratories
  •         Cleanroom manufacturing
  •         Wet lab testing
  •         Global supply chain

KMC provides customers with streamlined, customized, cost-saving solutions for complex medical manufacturing projects. Whether medical systems have just completed the design phase or have been in production elsewhere, we assume responsibility for the entire manufacturing process. We apply our knowledge of medical instrument engineering and manufacturing to smooth the transition from design to full-scale production. We provide transition service for products developed externally and internally. Our engineering team use proven processes – including a proprietary Manufacturing Readiness Review checklist – to reduce time-to-market and eliminate unnecessary costs.

  •         Diagnostic Imaging
  •         Microbiology Applications
  •         Life Science
  •         Laboratory Automation
  •         Immunoassay Analyzers
  •         Hematology
  •         Clinical Chemistry
  •         Point of Care 

Is your product design ready for medical manufacturing? Download our Manufacturing Readiness Review Checklist to find out. 

Download KMC's Manufacturing Readiness Review Checklist

 Our Manufacturing Execution System (MES) Provides:

  • Rapid Ramp-Up
    Our software platform is customized for each project and provides step-by-step, visual instructions. 
  • 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.
  • Regulatory Compliance
    KMC Systems’ manufacturing execution system also manages documentation for traceability and regulatory compliance.
  • Customer Access
    Our MES can provide customers with web-based access to manufacturing reports.

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KMC Systems medical manufacturing customers rely on our extensive experience in medical device manufacturing and our demonstrated record of success.