Ghent, Belgium — 07 October 2026
RheumaFinder, the Ghent-based UZ Gent spin-out developing AI-driven CT screening support for structural bone lesions associated with axial spondyloarthritis (axSpA), has officially achieved ISO 13485:2016 certification — the internationally recognized quality management standard for medical device manufacturers. The certificate was issued by Kiwa Assurance (part of the Kiwa Group, Notified Body NB 1912), following successful completion of the Stage 1 and Stage 2 audits, with zero major non-conformities identified.
Why this matters
ISO 13485 certification confirms that RheumaFinder has established and operates a quality management system aligned with the requirements applicable to the design, development and support of regulated medical devices throughout their lifecycle. The QMS provides the framework for key activities including risk management, design and development controls, verification and validation, clinical and regulatory activities, supplier controls and post-market processes.
For RFMaple, a Class IIa Software as a Medical Device under the EU Medical Device Regulation (EU MDR), ISO 13485 certification represents an important component of the regulatory pathway towards CE marking. It complements the technical documentation, clinical evaluation and conformity assessment activities required under the EU MDR.
A consistent audit track record
The certification extends a consistent regulatory and quality track record across RheumaFinder’s activities to date, with zero major findings identified during the ISO 13485 Stage 1 and Stage 2 audits, as well as during the first review of the MDR Technical Documentation.
These outcomes reflect RheumaFinder’s continued focus on building a robust, controlled and continuously improving quality and regulatory framework to support the development and future lifecycle management of RFMaple.
What’s next
With ISO 13485 certification achieved, the next logical step is to continue the EU MDR conformity assessment process towards CE marking of RFMaple. RheumaFinder will continue working with its Notified Body on the remaining regulatory and technical documentation activities required to complete this process.
In parallel, the company is preparing for the U.S. FDA 510(k) pathway, with further regulatory interaction planned as part of the preparation for potential future market placement of RFMaple in the United States.
Together, these activities mark an important next phase for RheumaFinder as it progresses from the establishment of its quality and regulatory foundations towards market readiness and the future availability of RFMaple.