Quality management

To help ensure a smooth life cycle for your product we infuse quality into every step of the manufacturing process.

Quality Management

Quality highlights

  • ISO 13485 certification
  • FDA QSR compliance
  • Registered with the FDA as a medical device manufacturer
  • Black-belt certified engineers
  • Real-time statistical process control (SPC)
  • Deploy lean manufacturing/Six Sigma tools
  • Validated processes
  • IQ, OQ, PQ procedures
  • Process Failure Modes Effect Analysis (PFMEA)
  • Design of Experiments (DOE)
  • Control plans

Quality solutions

We understand that the components and devices we create are critical to health and well-being. So when we bring your medical device to life, we infuse stringent quality standards into every step.

At Tegra Medical, quality is never a compromise.

Automated quality testing
Quality examination

Massachusetts ISO


Mississippi ISO

Quality management

Costa Rica ISO


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