UgenTec - IVDR for labs

“The EU IVDR puts specific requirements on labs – spanning GSPR compliance, performance validation, and documenting and justifying the lab’s approach. FastFinder helps labs comply on all fronts.”

– K. Hensen, Regulatory & Quality –

The new EU IVDR Regulation
... and how UgenTec helps

A Knowledgeable
Partner

Our regulatory team will help you by providing document templates, checklists, and a full-fledged validation package.

Facilitating Performance Validation

We help you put together validation reports for PCR assays with real test cases, document templates, and guidelines.

The lab's different use cases – labs vary in testing approach.
Find how UgenTec fits yours.

I am using commercial off-the-shelf assay kits. How does FastFinder help?

I am using commercial kits, and I optimize them for improved performance.

I am using lab-developed,
'in-house' tests. How does FastFinder help?

Navigating the EU IVDR.

UgenTec as a knowledgeable partner.

Learn more in our IVDR Webinar

Still have questions?