MDR Certification

We are thrilled to announce that Comeo has officially been certified under the Regulation (EU) 2017/745 Medical Device Regulation (MDR) by our notified body BSI, following a successful conformity assessment of our Quality Management System (QMS) and our flagship solution, ComeoCare. 

 This is a significant validation of ComeoCare’s design, development, and deployment process, underscoring its compliance with the highest safety, performance, and traceability standards required under this regulation. 

 This certification marks a turning point in Comeo’s evolution toward full regulatory compliance and international scale. With MDR approval under our belt, we’re positioned to expand into new markets, building upon our Swiss and Belgian success and upcoming growth in the European healthcare space. We thank our exceptional internal teams, trusted partners, and the experts at BSI for their rigorous assessment and support throughout this journey. 

Check out the certificate here.

 About ComeoCare 

ComeoCare is a CE-marked digital platform designed to manage complex, regimen-based treatments such as oncology therapies. It supports the entire medication workflow, from prescription and compounding to dispensing and administration. The platform enables seamless collaboration across disciplines - pharmacy, oncology, nursing, laboratories - to ensure closed-loop workflows, minimise medication errors, and support regulatory compliance and clinical accreditation. 

 ComeoCare is currently deployed in over 30 healthcare institutions across Belgium and Switzerland, supporting 500+ active users and managing the treatment of more than 750 patients daily.