Medicus AI, the Vienna-based health tech company, today announced that it 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.
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.