At XOresearch SIA, the manufacturer of Cardio.AI, our mission is to deliver unparalleled clinical intelligence in cardiology. The integrity of diagnostic data is non-negotiable, and compliance is the bedrock upon which clinical trust is built.
We are proud to announce that our medical device software application, Cardio.AI, designed for advanced ECG analysis, has successfully been certified under the stringent EU Medical Device Regulation (MDR) 2017/745 and has also been certified for the rigorous EN ISO 13485:2016 Quality Management System.
This significant dual milestone, overseen by the accredited Notified Body TÜV SÜD Product Service GmbH (NB 0123), validates the methodological precision and foundational quality of our entire operational framework.
The Nexus of Clinical Innovation and Regulatory Excellence
The development of sophisticated Software as a Medical Device (SaMD) for critical diagnostics, such as long-term ECG analysis, requires absolute transparency and demonstrable effectiveness.
MDR (EU 2017/745): The Mandate for Safety and Performance
The successful evaluation of our quality management system confirms that our device meets the essential requirements for safety, performance, and risk management under the EU MDR. Our software solution is classified as a Class IIa Medical Device.
The MDR certification covers the full lifecycle of our platform: the design, development, manufacture, servicing, installation, and distribution of a medical device software application dedicated to acquiring, analyzing, visualizing, and reporting electrocardiogram (ECG) data. For cardiologists, this status assures that the data they rely on for critical diagnostic decisions—especially in complex, long-duration monitoring—is processed by a compliant, high-assurance system.
The MDR certificate is valid from October 6, 2025, until October 5, 2030.
ISO 13485: The Architecture of Quality
Complementing the MDR, the ISO 13485:2016 standard certifies our exhaustive Quality Management System (QMS). This confirms that quality is systematically integrated into every phase of our product’s lifecycle, ensuring consistency and reliability from the initial concept to post-market surveillance. For a SaMD focused on deep data analysis, this methodological rigor is essential for maintaining data integrity and diagnostic accuracy over time.
The ISO 13485 certificate is valid from September 18, 2025, until September 17, 2028.
Paving the Path for Next-Generation Cardiology Tools
In the rapidly evolving landscape of digital cardiology, where tools like Cardio.AI are leveraging AI for faster annotation and interpretation, foundational compliance is the prerequisite for trust.
By rigorously meeting these global standards, XOresearch SIA provides the clinical community with the confidence required to integrate advanced ECG analysis tools into their daily practice. This achievement paves the way for continued innovation, allowing us to focus on the next generation of diagnostics, knowing that our platform’s integrity is secured by the highest possible regulatory benchmark.