Engineering
Engineering and support services for spine, trauma, and extremity medical implants
Comprehensive engineering and support services
At SpiTrex Orthopedics, we specialize in providing comprehensive engineering and support services for the production of spine, trauma, and extremity medical devices. Our experienced team of design engineers and manufacturing experts use a variety of approaches to ensure that every aspect of the manufacturing process supports efficient, high-quality production.
Our team provides support for process validations and capability studies to ensure that every product is manufactured with consistent quality. We also offer expertise in risk management and Failure Modes and Effects Analysis (FMEA) to ensure that every product meets regulatory requirements and is safe for use.
Verification and validation
Our verification and validation (V&V) support services ensure that every product is thoroughly tested and meets the highest standards of quality. Our state-of-the-art testing facilities and experienced team allows us to perform a wide range of tests, including fatigue testing, chemical analysis, and more.
Documentation support
We also provide comprehensive documentation support, including assistance with CE Mark and FDA file preparation. Our team works closely with clients to ensure that all necessary documentation is complete and accurate, facilitating the approval process.
At SpiTrex Orthopedics, we understand that successful medical device production requires open and honest communication with our clients. We provide regular progress updates and collaborate closely with clients to ensure that their needs are met at every step of the process.
Contact us today to learn more about how we can help you with your spine, trauma, or extremity medical device project.
