Canatu Plc has achieved ISO 13485:2016 certification, marking a significant milestone for its point-of-care diagnostics programme, 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 recognised quality management system (QMS) standard for medical devices and IVD, showing the company’s commitment to quality, regulatory compliance, and development of next-generation diagnostic technologies.
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.
Advancing quality and regulatory readiness
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.
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 commercialisation activities in major healthcare markets across the United States and Europe.
Strengthening the foundation for future diagnostics innovation
This achievement marks a key step in scaling Canatu’s Medical Diagnostics business, reinforcing the company’s position as a trusted partner for high-performance sensor solutions in healthcare applications.
“Achieving ISO 13485 certification is a significant milestone for our Medical Diagnostics business unit,” says Nedal Safwat, Chief Development Officer, Medical Diagnostics at Canatu. “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.”
At the core of Canatu’s diagnostics offering is its proprietary carbon nanotube (CNT) sensor platform, which enables highly sensitive and reliable electrochemical sensing, addressing the growing demand for rapid, precise, and scalable point-of-care diagnostic tools.
Canatu to showcase its technology at ADLM 2026
Canatu will present three scientific posters at ADLM 2026, the Association for Diagnostics & Laboratory Medicine Annual Scientific Meeting & Clinical Lab Expo, taking place on 26–30 July 2026 in Anaheim, California. The posters will showcase advances in the company’s CNT electrochemical biosensing platform.