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.

ISO certificates

View all of our ISO certificates.

As Tegra Medical extends operations into Europe and Asia some of the ISO certificates will continue to show the names of SFS, Stamm, and Unisteel.

Automated quality testing

: 0