Medicus AI, the Vienna-based health tech company, today announced that it had received a Class I Medical Device CE Mark for its mobile application. This confirms that Medicus AI conforms to the requirements of the Medical Devices Directive 93/42/EEC.
Mouhammad Kawas, Chief Technology 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.”
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.
Kawas said:
“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.”
For the uninitiated, 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.
To complete the certification process, Medicus AI worked with the Johner Institute to navigate the complex medical device approval processes. Since securing the Class I CE Mark approval, Medicus AI has commenced its application process for Class IIa CE Mark certification.
Kawas added:
The certification requires us to have better documentation, generate reports, and another important measure that ensures both quality and safety.
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.
Main image picture credits: Medicus AI
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