Digital Health App Medicus AI Earns CE Certification Mark

Medicus AIMedicus AI, the Vienna-based health tech company, has received a ​Class I Medical Device CE Mark for its mobile application. The CE certification mark confirms that Medicus AI conforms to the requirements of the Medical Devices Directive 93/42/EEC. The Directive outlines safety and performance requirements for medical devices in the EU. A product bearing the CE mark can be freely sold anywhere in the EU.

The CE certification mark is a key milestone for a fast-growing company such as Medicus AI. As a European-based enterprise, the certification is essential as it continues to expand in territories ranging from South America to China.

Mouhammad Kawas, Chief Technical Officer, Medicus AI ​said, "The CE mark certification process was a challenging and necessary 18-month journey that led to rethinking our application development process from the ground up. This included looking critically at the quality assurance, technical and code review measures that we follow at Medicus, in particular with an eye at our expansive growth, both in terms of our product offering and our geographical reach."

To complete the certification process, Medicus AI worked with the​ ​Johner Institute to navigate the complex medical device approval processes, ensuring documentation compliance, quality management, and usability testing were aligned for medical device approval with the support of regulatory specialists, auditors, and engineers.

"The certification requires us to have better documentation, generate reports and another important measure that ensures both quality and safety. For example, it forces us to think a little further, looking at all potential use cases and outcomes to identify all the risks in our product and mention how we are working to mitigate them.

"We didn't stop there. We also implemented comprehensive training modules that we follow in all aspects of the work we do, from product design and medical scopes to content development and technical development," added Mouhammad.

Led by the Medical & Sciences team at Medicus, the work undertaken to earn the CE mark included an in-depth review of all medical content to ensure medical validation by cross-referencing all content with sources and country-specific guidelines and databases.

Dr. Nadine Nehme, Chief Science Officer, Medicus AI, ​said "The CE Mark approval is a notable achievement for Medicus AI. The application process required stringent regulatory reviews against the strictest clinical processes."

"In adherence to CE certification, our content is carefully prepared, taking into account both ethical considerations and the usefulness to our users. For example, the terms we employ are considered descriptive clinical findings and do not imply a diagnosis, so we opt for the use of suggestive rather than affirmative words when describing a result like 'could' and 'might'. Our aim is to provide insights and suggest examples; never to give a diagnosis," explained Dr. Nehme.

Since securing the Class ​I​ CE Mark approval, Medicus AI has commenced its application process for Class IIa CE Mark certification.

For further information, please visit:
https://medicus.ai

About Medicus AI

Medicus is a fast-growing ambitious company committed to bringing health literacy and positive behavioral change to patients and users everywhere by building innovative tech products that transform businesses and improve people's lives.

Our mission is to contribute to today's continuously evolving healthcare industry by changing the way doctors and patients think about health. We have an obsessive and meticulous approach to data privacy and protection, believe ardently in the democratization of health data, and place ethical considerations above all else.

We build products that are smart and intuitive, tell a clear story, and are a pleasure and delight to use. We place the patient and user at the center of everything we do and build products that are meaningful and improve the lives and jobs of everyone in the healthcare ecosystem.

Most Popular Now

Giving Doctors an AI-Powered Head Start …

Detection of melanoma and a range of other skin diseases will be faster and more accurate with a new artificial intelligence (AI) powered tool that analyses multiple imaging types simultaneously...

AI Medical Receptionist Modernizing Doct…

A virtual medical receptionist named "Cassie," developed through research at Texas A&M University, is transforming the way patients interact with health care providers. Cassie is a digital-human assistant created by Humanate...

Using Data and AI to Create Better Healt…

Academic medical centers could transform patient care by adopting principles from learning health systems principles, according to researchers from Weill Cornell Medicine and the University of California, San Diego. In...

Northern Ireland Completes Nationwide Ro…

Go-lives at Western and Southern health and social care trusts mean every pathology service is using the same laboratory information management system; improving efficiency and quality. An ambitious technology project to...

AI Detects Hidden Heart Disease Using Ex…

Mass General Brigham researchers have developed a new AI tool in collaboration with the United States Department of Veterans Affairs (VA) to probe through previously collected CT scans and identify...

AI Tool Set to Transform Characterisatio…

A multinational team of researchers, co-led by the Garvan Institute of Medical Research, has developed and tested a new AI tool to better characterise the diversity of individual cells within...

Human-AI Collectives Make the Most Accur…

Diagnostic errors are among the most serious problems in everyday medical practice. AI systems - especially large language models (LLMs) like ChatGPT-4, Gemini, or Claude 3 - offer new ways...

Highland Marketing Announced as Official…

Highland Marketing has been named, for the second year running, the official communications partner for HETT Show 2025, the UK's leading digital health conference and exhibition. Taking place 7-8 October...

MHP-Net: A Revolutionary AI Model for Ac…

Liver cancer is the sixth most common cancer globally and a leading cause of cancer-related deaths. Accurate segmentation of liver tumors is a crucial step for the management of the...

Groundbreaking TACIT Algorithm Offers Ne…

Researchers at VCU Massey Comprehensive Cancer Center have developed a novel algorithm that could provide a revolutionary tool for determining the best options for patients - both in the treatment...

The Many Ways that AI Enters Rheumatolog…

High-resolution computed tomography (HRCT) is the standard to diagnose and assess progression in interstitial lung disease (ILD), a key feature in systemic sclerosis (SSc). But AI-assisted interpretation has the potential...