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

Unlocking the 10 Year Health Plan

The government's plan for the NHS is a huge document. Jane Stephenson, chief executive of SPARK TSL, argues the key to unlocking its digital ambitions is to consider what it...

Alcidion Grows Top Talent in the UK, wit…

Alcidion has today announced the addition of three new appointments to their UK-based team, with one internal promotion and two external recruits. Dr Paul Deffley has been announced as the...

AI can Find Cancer Pathologists Miss

Men assessed as healthy after a pathologist analyses their tissue sample may still have an early form of prostate cancer. Using AI, researchers at Uppsala University have been able to...

New Training Year Starts at Siemens Heal…

In September, 197 school graduates will start their vocational training or dual studies in Germany at Siemens Healthineers. 117 apprentices and 80 dual students will begin their careers at Siemens...

AI, Full Automation could Expand Artific…

Automated insulin delivery (AID) systems such as the UVA Health-developed artificial pancreas could help more type 1 diabetes patients if the devices become fully automated, according to a new review...

How AI could Speed the Development of RN…

Using artificial intelligence (AI), MIT researchers have come up with a new way to design nanoparticles that can more efficiently deliver RNA vaccines and other types of RNA therapies. After training...

MIT Researchers Use Generative AI to Des…

With help from artificial intelligence, MIT researchers have designed novel antibiotics that can combat two hard-to-treat infections: drug-resistant Neisseria gonorrhoeae and multi-drug-resistant Staphylococcus aureus (MRSA). Using generative AI algorithms, the research...

AI Hybrid Strategy Improves Mammogram In…

A hybrid reading strategy for screening mammography, developed by Dutch researchers and deployed retrospectively to more than 40,000 exams, reduced radiologist workload by 38% without changing recall or cancer detection...

Penn Developed AI Tools and Datasets Hel…

Doctors treating kidney disease have long depended on trial-and-error to find the best therapies for individual patients. Now, new artificial intelligence (AI) tools developed by researchers in the Perelman School...

Are You Eligible for a Clinical Trial? C…

A new study in the academic journal Machine Learning: Health discovers that ChatGPT can accelerate patient screening for clinical trials, showing promise in reducing delays and improving trial success rates. Researchers...

Global Study Reveals How Patients View M…

How physicians feel about artificial intelligence (AI) in medicine has been studied many times. But what do patients think? A team led by researchers at the Technical University of Munich...

New AI Tool Addresses Accuracy and Fairn…

A team of researchers at the Icahn School of Medicine at Mount Sinai has developed a new method to identify and reduce biases in datasets used to train machine-learning algorithms...