ArtiQ obtains ISO 13485 and CE marking (MDR) certification

Leuven, Belgium, Thursday, January 28th, 2021 – ArtiQ, a Belgian start-up with the mission to empower medical professionals with artificial intelligence to timely and accurately diagnose, treat, and follow-up patients with lung diseases, has obtained ISO 13485 and CE marking (MDR) certification.

Both certificates are recognition for ArtiQ’s quality-focused approach and confirm that the ArtiQ quality management system is in line with the latest standards. This independent recognition assures partners that they are not only working with an innovative start-up but also with a professional medical device company with a quality management system that meets the industry standards.

Marko Topalovic, CEO and co-founder of ArtiQ: “This is an incredibly important milestone in the short life-time of our company. I believe that quality is an essential competence and obligation of every medical device company, which is why I am very proud of our team to achieve this. This allows us to continue securing on-time diagnosis and improve outcomes of patients with respiratory diseases across the complete European market. It also represents a good base for efficient growth outside Europe.”

The CE marking certification for the ArtiQ.PFT software puts ArtiQ in a great position for the transition to the MDR regulations. It ensures that the ArtiQ.PFT software can remain available on the market after the transition period in European regulations. Equally important, it prepares the company to continue to improve and build on the software and adapt it to changing and/or local guidelines.

Marko Topalovic, CEO and co-founder of ArtiQ: “To the best of our knowledge, there are only a handful of medical software companies that obtained the Class IIa certification according to the latest European Medical Device Regulations. I am happy that our team lays the groundwork for MDR in Belgium.”

About ArtiQ & ArtiQ.PFT

ArtiQ is a young, dynamic, and innovative spin-off company of the University of Leuven (Belgium). The company was founded in early 2019 by four committed founders with an extensive history in respiratory medicine, medical devices, and artificial intelligence. ArtiQ’s mission is to empower medical professionals with artificial intelligence to accurately and timely diagnose, treat and follow-up patients with lung diseases.

The ArtiQ.PFT software automates the interpretation of pulmonary function tests (PFTs). It reduces the administrative burden to allow pulmonologists to focus on clinical decision making and patient consult. ArtiQ.PFT uses artificial intelligence (AI) to support the detection of disease patterns early on in the diagnostic process and thus holds the potential to reduce redundant testing.