It is with pride that we would like to share the success of our AI start-up client relios.vision GmbH in obtaining the CE mark for its medical device software (MDSW) GadoBoost® in a record time of 15 months from start to end (12 months of development and compliance building + 3 months of conformity assessment). As a spin-off from the University of Bonn, relios.vision translated their academic research findings into an AI-based MDSW for the amplification and detection of pathological contrast enhancement signals in cranial MRI scans. 

Qserve got involved in relios.vision’s MDR project at a very early stage in July 2024, first drafting their regulatory strategy, followed by designing and implementing an ISO 13485-compliant quality management system, coordinating and co-creating technical documentation, and supporting MDR conformity assessment and QMS certification audits. relios.vision’s technical documentation was submitted to its notified body TÜV SÜD Danmark for conformity assessment at the beginning of July 2025. The technical documentation review successfully ended in the first week of September after only 1 round of questions. QMS certification audits were also concluded at the beginning of September, with only two minor non-conformities.

This outstanding achievement underscores the critical importance of integrating regulatory, quality, and clinical experts into the startup team from the earliest stages of medical device development. Their involvement provides essential clarity and structure around regulatory and quality compliance, accelerating the conformity assessment process while ultimately reducing costs by minimizing review cycles with notified bodies and avoiding costly iterations. Even a young startup can achieve seamless MDR compliance and bring products to the EU market in just over one year when regulatory and quality considerations are embedded into its foundation from day one.

A big congratulations to the involved Qserve consultants: Bingshuo Li, PhD and Maria Cámara Torres, PhD. Bingshuo is a subject matter expert in MDSW, AI, and cybersecurity compliance, and a qualified QMS lead auditor. Maria is an expert in clinical strategy, clinical evaluation, and post-market clinical follow-up.  

Would you like to learn more about obtaining a CE mark quickly and efficiently? Get in touch.