Zana earns ISO 13485 Certification, reinforcing commitment to high-quality healthcare technology

A forerunner in Voice AI-driven digital health solutions, Zana has reached a significant milestone by obtaining ISO 13485 certification, underscoring its commitment to the highest standards of medical device quality management. This achievement highlights Zana’s dedication to delivering safe, effective, and regulatory-compliant solutions that empower self-management and enable remote care, while providing objective real-world health measures.

Zana has been pioneering since 2018 the use of digital patient companions powered by Voice AI, helping to transform healthcare through innovative, data-driven insights. By integrating intelligent voice technology with medical-grade quality standards, Zana is advancing the future of personalized and proactive healthcare. The ISO 13485 certification validates the company’s ability to meet stringent regulatory requirements in the design, development, and deployment of healthcare solutions.

"Achieving this certification marks another significant step in our journey of bringing high-quality, AI-powered healthcare solutions to the market," said Dr. Julia Hoxha, CEO of Zana. "We are committed to building trustworthy, clinically-validated technology that enhances patient care, empowers healthcare providers, and meets the highest industry standards for safety and effectiveness."

The company is focused on securing regulatory approval as a medical device according to the new Medical Device Regulation, ensuring its patient engagement solutions and Voice AI-powered digital biomarkers are seamlessly integrated into clinical workflows and digital health ecosystems.

Zana’s ISO 13485 certification not only reinforces its commitment to quality and patient safety, but also serves as a crucial foundation for its expansion and regulatory pathway. This milestone positions Zana as an important player in the evolving digital health and medical AI landscape, fostering trust among healthcare professionals, patients, and industry stakeholders.