In Vitro Diagnostic Regulation (IVDR) Education

Blog posts

idvr-ready-blog

Getting Ready for the IVDR

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Three Steps You Can Take to Navigate The IVDR

paper-overview-lab-guidance-blog

Paper Overview: Regulatory Guidance for Clinical Laboratories

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7 Things to Know Before Establishing an LDT

idvr-vs-ivdd

IVDD vs. IVDR: Classifications Defined and Compared

solutions-pandemic-control-blog

COVID-19 Technologies Point to Reliable Pandemic Control Solutions

Resources

Analytical validation (AV)—a pathway to quality

IVDR Services and Support Flyer

White Paper: Overcoming the Complexities of your In Vitro Diagnostic Regulation (IVDR) Transition

Frequently asked questions

Get your IVDR questions answered regarding compliance, LDTs, transition timelines, and more.

Learn more ›

Solutions

Researchers and pathogens

TaqPath COVID-19 Testing Solutions

Have everything to be ready for anything. Rely on an extensive portfolio of tailored solutions to meet your needs as they evolve.

Genexus Dx Integrated Sequencer

Fast, automated targeted NGS for your clinical lab

Genomic insights in as little as 24 hours with the CE-IVD market Ion Torrent Genexus Dx Integrated Sequencer.

QuantStudio 5 Dx System

Accurate, sensitive, and reliable real-time PCR system

The QuantStudio 5 Dx system is an in vitro diagnostic device intended to perform fluorescence-based PCR to provide detection of nucleic acid sequences in human-derived specimens.

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