Our Commitment
to Quality

At Congenica the quality of our software and the insights that it provides for patients is paramount.

Congenica is a CE Marked medical device

Congenica is a CE Marked IVD clinical decision support platform for clinical diagnostic use in inherited genetic disorders in the EU, Iceland, Lichtenstein, Norway, Switzerland, Turkey, and UK.

Congenica also complies with HIPAA and GDPR requirements. Using Congenica software, our in-house team of clinical scientists have been awarded the highest marks by the independent quality assessment provider for genomics, GenQA.

What does this mean for my lab?

Using Congenica for clinical diagnosis means more life-changing answers for patients with rare or inherited genetic disorders.

As a CE Marked In Vitro Diagnostic (IVD), you can now use Congenica for the clinical diagnosis of patients with rare or hereditary genomic disorders.

On average, laboratories analysing genetic data with Congenica achieve a 30% higher diagnostic yield in heterogeneous rare disease cases compared to their previous clinical workflows.

Why is quality important?

Regulatory compliance is essential for patient safety and the effective application of genomic medicine for clinical use.

Congenica is now the only CE Marked IVD software for clinical diagnosis of rare and inherited genetic disorders that is available globally in both cloud and on-premise deployments and can fully integrate with your systems for seamless transfer of patient data and reports.

This enables you to use Congenica for diagnosing heritable genetic diseases as part of routine medical care.

Obtaining the CE mark is testament to the quality of Congenica’s software platform. As the regulatory landscape continues to evolve, we are committed to remaining ahead of the game with regards to meeting the strong requirements in our industry.

Jonathan DaySenior Director of Regulatory Affairs and Quality Assurance, Congenica

Future-proof your clinical operations

In 2022, EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) introduces a major update to the regulatory framework, replacing IVDD.

Under the new IVDR, all labs performing Laboratory Developed Tests (LDTs) in the European Union will have to use a CE Marked IVD device or justify why they are not doing so for regulators.

By using Congenica you are well positioned for when the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 comes into place in May 2022. With Congenica, you have full peace of mind to be ready for IVDR.

Congenica complies with international best practice standards ensuring confidence in the quality and security of Congenica software.



ISO 27001
Information Security Management
EN ISO 13485
Medical Devices - Quality Management Systems
EN ISO 14971
Medical Devices - Application of Risk Management
EN 62304
Medical Devices - Software Life Cycle Processes
EN 62366
Application of Usability Engineering to Medical Devices
Clinical Risk Management

Don’t risk non-compliance with IVDR

Analyze, Interpret and Report NGS data automatically


  • Reduce your workload, analysis times and costs

  • Increase case throughput and diagnostic accuracy

  • Improve outcomes for patients and their families

  • Have peace of mind that you comply with regulatory best practice

Analyze and interpret genomic data rapidly, reliably and with complete confidence