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Navigating the EU IVDR.

UgenTec as a knowledgeable partner.

Karen_Hensen

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

Spreadsheets

A Knowledgeable
Partner

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

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Prep Automation

Facilitating Performance Validation

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

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Learn more in our IVDR Webinar

Navigating the EU IVDR: UgenTec as a knowledgeable partner

Watch our IVDR Webinar

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

PCR Kit Manufacturer

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

Find the answer
Prep Automation

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

Find the answer
Complete Lab

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

Find the answer

Still have questions?

Talk to our Regulatory and Quality experts

Get in Touch
Start with FastFinder
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Contact: info@ugentec.com | +32 78 48 44 79 | VAT number: BE05 5197 6421