UgenTec | Quality

Our software platform is built from the ground up for clinical use, developed under a Medical Device Quality Management System.

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.

UgenTec partners with small and large global enterprises on strategies for IVDR implementation.

How FastFinder supports your IVDR 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.

Submitting your assay to the FDA with our software in 3 steps:

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:

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