Canatu Receives ISO 13485 Certification

Canatu Plc has achieved ISO 13485:2016 certification, marking a significant milestone for Canatu’s point-of-care diagnostics program, currently in development, and in the company’s readiness for regulated in vitro diagnostics (IVD) markets. 

Attainment of this certification demonstrates that Canatu meets the internationally recognized quality management system (QMS) standard for medical devices and IVD, showing Canatu’s commitment to quality, regulatory compliance, and development of next-generation diagnostic technologies.

The certification strengthens Canatu’s ability to develop diagnostic technologies in accordance with global regulatory expectations and provides an important foundation for future regulatory submissions and commercialization activities in major healthcare markets across the United States and Europe.

ISO 13485 certification covers the design and development of electrochemical sensor technology and IVD medical devices, confirming that Canatu is operating under a fully controlled, documented, and traceable QMS aligned with stringent regulatory requirements.

“Achieving ISO 13485 certification is a significant milestone for our Medical Diagnostics business unit.” Nedal Safwat, Chief Development Officer, Medical Diagnostics at Canatu, said, “It reflects the strength of our quality management system, the speed and agility of our team in building the foundation and earning certification in record time, and our commitment to advance the development of the next-generation diagnostic technologies. This certification enhances our ability to collaborate with partners and accelerate the path to market for innovative point-of-care IVD solutions.”

The certification audit was completed with zero nonconformances, highlighting the maturity of Canatu’s quality processes and providing a strong foundation for future partnerships, product development, and market access.