Tonic Easy Medical earns ISO 42001 certification

The milestone reinforces the company as the new benchmark for safe, trusted healthcare AI across Europe.
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PORTO, PORTUGAL - Tonic Easy Medical [https://tonicapp.io/] announced today that it has become one of the first companies in Europe to be certified under the ISO/IEC 42001:2023 standard for AI management systems, reinforcing its leadership in safe and responsible clinical AI.

Tonic is a digital platform for medical doctors that brings together clinical and educational tools in a single environment, supporting over 200,000 physicians in their daily practice across France, Italy, Spain, and Portugal. It was also one of the first platforms to integrate a clinical AI copilot - Tonic AI - adopting early the safety, reliability, and transparency standards required for the use of artificial intelligence in healthcare.

Tonic AI is experiencing exponential growth: in 2024 alone, usage increased by 265%, with over 3.2 million clinical queries submitted by 55,900 physicians of all specialties. Nearly half (49%) of all doctors on the platform now use Tonic AI, which has become the most accessed resource.

Safety and regulatory compliance as strategic pillars

The regulation of medical AI is advancing quickly. Tools such as medical scribes - which transcribe consultations and manage clinical notes - are already required to be classified as medical devices by the U.S. FDA. Recently, in the UK, NHS leadership has also stated that these systems should be regulated as Class I medical devices due to their risk in patient care. Also during the month of June, the EU's Medical Device Coordination Group published Guidance MDCG 2025-4 on the safe making available of medical-device software (MDSW) apps on online platforms, confirming that AI-powered medical software offered through the app stores are in scope of Regulation (EU) 2017/745 and must satisfy both MDR safety-and-performance requirements and the transparency and risk-mitigation obligations under the Digital Services Act.

In this fast-changing AI regulatory landscape, Tonic Easy Medical is among the first European companies to be certified under the new ISO/IEC 42001:2023 standard for AI management systems, issued by BSI (AIMS 817029). This certification confirms compliance with established requirements for quality, safety, traceability, transparency, and reliability in AI systems.

The company is also undergoing the MDR conformity assessment process for its higher-risk AI systems under the European Medical Device Regulation (Regulation (EU) 2017/745) and for compliance with the EU AI Act's high-risk requirements - including risk-management, data governance, transparency and human-oversight controls. Its quality-management system is already certified to ISO 13485:2016 (certificate MD 800345), covering every stage of the medical-device life cycle, from design and development to validation, post-market surveillance and continual improvement.

Joao Guichard, the company's Chief AI Officer, said: "Building our AI as the tech and rules evolve has been really challenging, but also a big advantage. The regulations are shaping our process, and that's helping us grow into a mature AI company faster."

AI governance

AI strategy at Tonic is grounded in a strong AI governance framework that follows a risk-based approach.

This framework manages the design, development, deployment and ongoing operation of every AI system. Based in the guiding principle Primum non nocere (First, do no harm) it maps each AI component against its intended use, risk class, foreseeable misuse, and regulatory obligations.

Every model passes documented design-specification, verification and clinical validation gates, with bias, explainability and safety controls tested against predefined performance and usability metrics, with experts-in-the-loop - physicians and pharmacists. Once released, systems enter post-market surveillance: user-feedback telemetry, automated bias drift checks and periodic post-market surveillance reviews feed continuous improvement cycles.

This integrated, lifecycle-based governance ensures Tonic Easy Medical delivers AI tools with clinical value while remaining safe, transparent and fully compliant.

Daniela Seixas, CEO at Tonic Easy Medical, said: "AI risks are evolving fast. A few months ago, we saw physicians making somewhat naive questions to the AI and using few keywords as if they were doing a web search. Now, it is quite the opposite - they became very savvy, questions are very detailed, and they know exactly what they want from the machine. This means that now we are focused on preventing user overreliance on AI by developing safer models, encouraging answer verification and supplying links for verification when relevant, among other tactics."

Next steps

Tonic Easy Medical is planning to enhance its regulatory compliance efforts, recognizing this as a fundamental competitive advantage. In the coming months, it will adapt to local UK requirements and then to FDA regulations in the US.

About Tonic Easy Medical

Founded in 2016, Tonic Easy Medical is a digital health company that supports doctors in clinical decision-making through safe and validated digital tools. Designed by doctors, for doctors, Tonic is available in France, Italy, Spain, and Portugal, with upcoming expansion to the UK and Germany. It's used by over 200,000 physicians to make daily clinical practice more efficient, centralising essential resources like AI tools, medical calculators, CME-accredited content, decision trees, drug databases, job offers, medical news, and more.

The 43-employee scale-up was co-founded by Daniela Seixas, CEO, and Andrew Barnes, Christophe de Kalbermatten and David Borsos. Joao Guichard is leading the AI development efforts as Chief AI Officer (CAIO) and Cristiana Oliveira is managing the Regulatory and Compliance team.

Tonic was named by Forbes magazine as one of 60 female-led startups that are "shaking technology around the world". For more information visit: https://tonicapp.io/
Media Contact
Company Name: Tonic Easy Medical
Contact Person: Daniela Seixas
Email: Send Email [http://www.universalpressrelease.com/?pr=tonic-easy-medical-earns-iso-42001-certification]
Country: Portugal
Website: https://tonicapp.io/

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