As a start-up in MedTech, CE is the key to the market and a crucial element for market adoption and commercial success. As the CE process is very complex, time-consuming, and ever-changing, you need the right experts on board to guide you through the process and set up workable procedures and processes. MedQAIR provided this knowledge and experience and made our regulatory process a success. Both the software and the regulatory and cybersecurity knowledge helped us create workable and easy-to-execute procedures and processes, and helped us shape both our ISO 13485 QMS as well as the Technical File for Zeno AI, our MDR AI software for head and neck oncology.
They shaped the way we execute certain development processes and changed our view on what type of validation tests needed to be implemented and executed in order to meet the requirements. MedQAIR implemented these processes and trained the development team on how to execute and monitor these processes thoroughly. By doing so, it allowed the development team to ensure a step-by-step approach of executing these steps during normal development cycles and therefore ensuring compliant testing and validation.
Without MedQAIR, we would have never received ISO 13485 and CE-MDR in such a short timeline. Mid-2024 we had to switch notified body which was a risky, but necessary move. With MedQAIR’s support and expertise, we managed ISO 13485 certification roughly seven months later and CE-MDR 12 months later, which is extremely fast. Their support during surveillance audits is very hands-on and very helpful. Both on the back-end as well as the front-end of the whole regulatory pathway, MedQAIR supports on all aspects.
Within our field, we are the first mover and therefore it took a very long time to collect sufficient data to train an initial AI-model. Now that we have a dataset of more than 50.000 images (both benign and malignant), we can really boost the overall performance and therefore meet the market demand from the ENT field. From a regulatory perspective, meeting both the MDR and the AI-act can feel like a challenge and requires a solid, but flexible procedures and processes that are tailored for software development. MedQAIR created – in collaboration with our CTO – exactly the procedures and processes that demonstrated conformity with the requirements and provided the needed tests to show high performance and safety of our AI software.
MedQAIR ensured we were properly trained, re-trained and prepared for market release and beyond. They made sure the entire team is trained and updated periodically on certain key processes and that all personnel involved in the QMS and Technical File have a weekly workflow of ensuring all requirements and documentation are done on time and in high quality. Development and overall company processes are now following the specific standards and associated procedures and therefore always making sure all is up-to-date and executed in the right way. We are really happy with MedQAIR and their knowledge and hands-on approach and could not wish for a better consultancy firm in this space.
WSK Medical is a medtech startup developing Zeno AI, an MDR AI software solution for head and neck oncology. The company builds clinical-grade AI with regulatory readiness, cybersecurity, and ISO 13485 quality systems embedded into everyday development from the earliest stages.
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