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Manufacturing

Manufacturing: Finished Device Assembly

Finished Devices, Built Right

Finished Devices, Built Right

Enercon delivers precision finished device assembly with a focus on quality, efficiency, and traceability. We operate in a lean, single-piece flow environment supported by paperless manufacturing systems that enforce assembly routes, deliver electronic work instructions, and collect real-time quality data. Our precision-driven assembly approach meets the rigorous demands of Class 3 finished medical devices, where compliance, repeatability, and product integrity are critical.

Implementation of Lean Disciplines

Single-piece flow

Cellular manufacturing

Visual Factory

Detailed production metrics

Process staffing matrix

5S

Efficiency and Quality

Finished Medical Devices

  • ISO 13485 Certified
  • FDA Registered

In-House assembly and test fixture design and fabrication

Optical Assembly

Fluidics Assembly

MES Integrated Traceability and Genealogy Tracking

Process Failure and Risk Analysis