MDR Certification for two products developed by Graylight Imaging

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On August 5, 2026, Graylight Imaging received an EU Quality Management System Certificate in accordance with Regulation (EU) 2017/745 (MDR). This milestone marks a significant step in the company’s development. It signifies that the organisation has successfully transitioned from a software provider for external clients to a medical device manufacturer.

The MDR (Medical Device Regulation 2017/745) is an EU regulation governing the placing of medical devices on the European Union market.

MDR Certification: The Certification Process

The certification was conducted by the independent notified body TÜV Nord, which confirmed that our quality management system and product technical documentation comply with the requirements of the MDR, issuing a positive assessment in both areas.

This is a tremendous success for us and, at the same time, the result of long-term efforts. It was made possible by many months of work and dedication from our team of specialists, who have consistently strived – and continue to strive every day – to maintain the highest standards of quality, safety, and effectiveness in the solutions we develop.

MDR Certification for Two Medical Devices

Graylight Imaging has obtained MDR certification for two of its products:

BRIGHTER Medical Imaging Platform – software for analysing CT and MR images
Calcium Score Algorithm (CS GATED – Cardiac CT) – for assessing coronary artery calcification based on cardiac CT scans

Both products are Class IIa medical devices. The certificate confirms that our organisation’s quality management system complies with the requirements for design, manufacturing, final inspection, and post-market surveillance set forth in EU Regulation 2017/745, widely known in the industry as the MDR.

BRIGHTER as a Certified Viewer

One of the solutions that has obtained MDR certification is the BRIGHTER Medical Imaging Platform, an advanced platform for analysing computed tomography (CT) and magnetic resonance imaging (MRI) scans.

This DICOM file viewer forms the foundation of the BRIGHTER ecosystem, enabling physicians not only to view examinations but also to perform automatic analysis, including CT angiography images. Currently, BRIGHTER is primarily focused on cardiology.

The platform is based on a modular architecture, which means that algorithms for the automatic analysis of medical images – tailored to the needs of a medical facility or physician – can be added to it. The solution can be flexibly expanded with additional algorithms that support diagnostic imaging, particularly in cardiology and the comprehensive analysis of cardiac images.

BRIGHTER from anywhere in the world

The solution operates as a web-based platform, providing doctors with secure access to test results from anywhere in the world. All of this is done through a web browser. All you need is internet access and your personal login credentials. This system architecture enables the organisation of e-consultations and e-consults among specialists. Doctors can jointly analyse the same images, conduct joint case evaluations, and exchange opinions in real time, regardless of their location.

Calcium Score Algorithm Certified Under MDR

Currently, the BRIGHTER system focuses on cardiac image analysis. Graylight Imaging is working on a suite of tools – algorithms for comprehensive cardiac analysis. One of them has just received MDR certification.

It is the Calcium Score Algorithm (CS GATED Cardiac CT). Like the BRIGHTER platform, it is certified under a quality management system compliant with Regulation (EU) 2017/745 (MDR) and classified as a Class IIa medical device. The solution automatically calculates the Calcium Score (Agatston Score) from non-contrast cardiac computed tomography (CT) scans, enabling a reliable, quantitative assessment of the degree of coronary artery calcification.

The system generates both an overall result and detailed data for individual coronary vessels: the left main coronary artery (LM), the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA). The analysis results are presented using clear colour-coded labels and numerical summaries.

At the same time, the physician retains control over the algorithm’s output. They can fully verify and correct the results by editing them. They can independently correct and approve the analysis results – including marked areas and vessel geometry – as well as remove, add, and modify the shape of atherosclerotic plaques.

Artificial Intelligence in Medical Imaging and Diagnostic Support

Both the BRIGHTER platform and the Calcium Score (CS GATED Cardiac CT) algorithm were developed to improve diagnostic efficiency by automating repetitive analysis steps, shortening examination processing time, and reducing the risk of interpretive discrepancies. The system serves a supportive role, leaving the final assessment to the physician. This approach promotes better use of available expert resources, which is particularly important amid a shortage of medical staff.

MDR Certification: Why We Needed It

Graylight Imaging’s attainment of MDR (Medical Device Regulation 2017/745) certification marks a milestone in the company’s development and confirms that the medical devices we have developed meet the European Union’s stringent requirements for safety, quality, and effectiveness. This certification allows us to legally market our products in the European Union, builds trust among hospitals, doctors, and business partners, and facilitates our participation in healthcare projects.

It also confirms the maturity of our quality and risk management processes, strengthens our competitiveness, and opens up opportunities for further growth. For medical software and AI-based solutions, MDR certification provides additional proof that the product meets the high regulatory requirements for use in everyday clinical practice. It is also proof that the technology we are developing is meaningful and has a future.