University of Porto spin-off is a pioneer in ISO certification for AI in healthcare
Tonic Easy Medical is one of the first European companies to be certified by ISO 42001, which defines best practices in the ethical and safe management of AI
Tonic Easy Medical, a spin-off from the University of Porto formerly known as TonicApp, has become one of the first European companies to obtain ISO/IEC 42001 certification — the new international standard that defines best practices for the ethical and safe management of artificial intelligence (AI).
This certification reinforces the company's position as a benchmark for responsible and reliable clinical AI in Europe.
In a rapidly evolving sector, this certification confirms that Tonic meets strict requirements in terms of quality, safety, traceability, transparency and reliability in its AI systems. For Daniela Seixas, the company's CEO, this is an essential step in keeping pace with the growing sophistication of medical users, who are increasingly demanding and experienced in the use of AI-based technologies.
Tonic has invested in developing models that prevent excessive reliance on AI, promote result verification, and integrate validation mechanisms, such as links to support clinical decision-making. João Guichard, Chief AI Officer, also points out that the demanding European regulatory environment has been a driver of maturity and innovation for the company.
The Tonic Easy Medical platform, developed "by doctors, for doctors", brings together clinical and educational tools used by more than 200,000 doctors in Portugal, Spain, France, and Italy.
Among its resources is Tonic AI — an AI clinical copilot that has already recorded more than 3.2 million clinical consultations in 2024 and is currently used by 49% of doctors registered on the platform.
Founded in 2016, Tonic is now preparing to expand into the United Kingdom and Germany, and is working to align its systems with the European AI Regulation and other international standards, including FDA regulations in the United States.
