Medical equipment demands the latest innovations, highest quality, fail-safe reliability, and critical requirements. The FDA requires that these life-critical devices must be developed, manufactured, and tested to the highest degree. Along with FDA and ISO 13485: 2016, SMC has integrated a traceability manufacturing program that can trace products down to the component level. Traceability of products is vital when working in the medical manufacturing field.

Our outstanding medical manufacturing qualifications include an FDA Registered Manufacturing Site (Registration No. 3009627223), ISO 13485:2016, and dedicated manufacturing cells.

SMC has manufactured medical products for twenty years and is committed to providing the medical industry with first-class products and customer service.

SMC Medical


  • FDA Registered Manufacturing Site (Registration No. 3009627223)
  • ISO 9001:2015 Registered
  • ISO 13485:2016 Registered for the Medical Device Industry
  • 8 Process Quality Designations including Six Sigma Black Belt Quality Engineering
  • Dedicated Medical Manufacturing Cells

Projects and Examples

Our capabilities in the medical field include, but are not limited to, the following:

  • Medical Imaging Equipment (MRI, PET, CT)
  • Patient Monitoring Systems
  • Wireless Diagnostic Equipment
  • Pharmaceutical Dispensing System
  • Oxygen Regulating Device
  • Biomedical Freezers

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