Cordys Analytics have officially reached two key regulatory milestones:
ISO 13485 certification, demonstrating that their quality management system meets the highest international standards for medical devices.
MDR certification, confirming that their Galvo™ ECG analysis platform complies with the EU Medical Device Regulation, one of the world’s strictest frameworks.
Their notified body, TÜV SÜD, has just confirmed these achievements. This represents a significant advancement for their team and technology.
With the Galvo™ 12L ECG analysis platform now fully certified, they are moving into the next stage: real-world clinical validation and commercialization.
Appreciation goes to their dedicated team, investors, and partners who helped make this possible.