UgenTec manages a strict quality management system that is ISO 13485 certified by SGS.
We’ve partnered with dozens of companies on quality strategies and regulatory submissions.
Include our Device Master File in your FDA submission.
A proven platform for your entire portfolio of assays and devices.
A validated end-to-end solution that enables a robust & reproducible clinical performance of your assay
An experienced quality management team with deep expertise in software submissions.
Include our software in your performance testing or update your performance data to include the software performance
Submit the software component as part of your device, referencing our platform Device Master File.
Partner with UgenTec to answer any questions the FDA might have regarding the software component of your device.
Want to learn more about our regulatory strategy and partnerships? Download our technical note below: