Quality Management
We embed quality at every stage of manufacturing to ensure a seamless product lifecycle.
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, stringent quality standards guide our every step.
At Tegra Medical, quality is never a compromise.
ISO certificates
View all of our ISO certificates.
Tegra Medical has operations Europe and Asia so some of the ISO certificates will continue to show the names of SFS, Stamm, and Unisteel.
Explore the GENESIS Tech Center®
Turn your ideas into reality with our state-of-the-art prototyping and product development services. Learn how we can help you bring your products to life.