Client Name
relios.vision GmbH
Industry : Medical Devices
Profile
relios.vision GmbH is a MedTech manufacturer specialising in AI-based medical imaging software. Its flagship product, GadoBoost®, enhances MRI contrast signals to improve the visibility of brain lesions, supporting radiologists in making more confident diagnostic decisions.
Business Challenge
To enter the EU market, relios.vision needed to achieve CE marking for GadoBoost® under the EU MDR. In parallel, the company faced challenges in identifying a Notified Body offering clear guidance, predictable timelines, and transparent communication to support its fast-paced software development cycle.
Our Solutions
Acting as Notified Body 2443, TÜV SÜD conducted the MDR conformity assessment for GadoBoost® and audited relios.vision’s quality management system against ISO 13485. TÜV SÜD supported the project with structured planning, clear timelines, transparent pricing, and dedicated expert guidance throughout the certification process.
Business Benefits
CE marking for GadoBoost® was achieved in just 98 days, enabling accelerated EU market entry. The structured and predictable assessment process ensured efficient certification, strengthened regulatory compliance and quality systems, and provided the client with confidence to support future growth and innovation.
