Furthermore, Tucuvi has received the ISO 13485 certification that guarantees the quality of its processes as a manufacturer of sanitary technology.
Tucuvi has achieved a major regulatory milestone: the first Clinical Voice AI to be certified as a Class IIb Medical Device under the EU Medical Device Regulation (MDR). This certification confirms that the technology meets the highest standards of clinical safety and effectiveness, enabling use in complex healthcare environments such as chronic patient monitoring and home care.
Additionally, the company has obtained the ISO 13485 certification, validating the quality and robustness of its processes as a medical technology manufacturer.
These certifications mark a new stage for Clinical Voice AI in Europe, reinforcing the technology’s credibility and regulatory alignment in clinical settings.
What does this mean for healthcare providers?
The certification as a Class IIb medical device represents more than a regulatory label. It follows rigorous external assessments that confirm the platform’s safety, reliability, and traceability in real-world use, offering stronger guarantees for healthcare professionals and institutions.
The ISO 13485 certification reinforces operational excellence, ensuring that all internal processes— design, development, production, and continuous improvement—are aligned with the most demanding standards in the medical device industry.
AI innovation must go hand in hand with evidence and safety—especially when dealing with clinical data, which is among the most sensitive and protected.Choosing certified solutions like the one we use with Tucuvi for remote patient monitoring allows us to move confidently toward a more efficient and responsible healthcare system, highlights Tania Menéndez, Digital Transformation Officer at Ribera Salud.
Scaling impact across Europe
In the past year, the use of Tucuvi’s platform, powered by LOLA, Tucuvi's clinical voice AI agent, has grown fivefold, enabling millions of clinical conversations with patients. The solution is currently in use across more than 10% of public hospitals in Spain, with three new hospitals integrating it every month.
Tucuvi has proven to be a reliable, intuitive, and fully scalable tool that enhances medical care without compromising data safety.As a healthcare professional, I especially value the transparency in how AI is managed and the close collaboration with their team, always open to clinical feedback, says Raquel Broullón, Nurse at Ribera Salud.
Read the full story in the official press release published by Diario Medico
