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Regulatory Compliance and Quality

We ensure that our customers comply with best regulatory practice

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

 

In Europe, our software complies with HIPAA and GDPR requirements and is a CE Marked IVD clinical decision support platform for clinical diagnostic use in rare diseases as well as inherited and somatic cancers in the EU, Iceland, Lichtenstein, Norway, Switzerland, Turkey, and UK.

Regulatory Compliance and Quality are paramount

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Regulatory compliance and quality are crucial for patient safety. To provide confidence in the effectiveness of our software, we follow strict quality guidelines throughout our organisation and our processes.

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You can be confident that our software has been thoroughly validated as stated in our intended use statements, and trust us to continuously improve our products to ensure patient safety and product effectiveness.

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 Day Chief Regulatory and Compliance Officer, Congenica

Our commitment to regulatory compliance and quality

Standard
Title

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 82304

Health Software - Part 1: General Requirements for Product Safety

EN 62366

Application of Usability Engineering to Medical Devices

DBC0129

Clinical Risk Management

Our Products and Services

Our products and services are consolidated on one single scalable, automated analysis platform that encompasses inherited disease, pharma insights and pathogen surveillance. Our platform is uniquely placed to drive ubiquitous use of complex data in routine clinical care.

OUR PRODUCTS OUR SERVICES

Our quality assurance

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