QUALITY ASSURANCE

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Regulatory compliance is not just a requirement—it’s our culture.

Quality is at the heart of everything KMC Systems does. Our robust ISO 13485 environment ensures that Design Controls and Manufacturing Operations are compliant. In addition, KMC operates an FDA-inspected site and undergoes numerous industry audits every year.

KMC Systems’ robust, FDA-compliant, automated software system has been customized over three decades to adhere to our strict processes and complex applications which ensures greater adherence to regulatory requirements. The resulting KMC Quality Management System (QMS) enables our QA team to adhere to regulatory requirements with confidence and proven success.

  • ISO 13485 Medical Device Guidelines
  • FDA Current and Good Manufacturing Practices (CGMP)
  • Calibration and Metrology
  • FDA QSR Parts 820, 803 and 806
  • Part 11 compliant software development
  • IEC 62304
Detailed QA documentation for compliance and corrective actions

Our Quality Management System provides step-by-step, visual instructions and streamlines documentation for traceability and regulatory compliance. Detailed, 3D-picture-based instructions reduce assembly time and enable a high level of workmanship. Each specially trained manufacturing technician follows the same precise, stage-gate process to completion. Alerts notify technicians and our Quality Assurance team of any out-of-tolerance data, allowing for rapid identification and correction.

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