- 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
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.
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.