Synaptiq shares how MedQAIR supported its path to CE marking by strengthening its Technical File and Clinical Evaluation, addressing notified body findings, and developing practical quality processes for an AI/ML-enabled medical device.
MedQAIR supported us primarily in strengthening our technical and clinical documentation so it meets the expectations of the notified body under MDR 2017/745. As an AI startup, translating our technical work into documentation that clearly demonstrates safety, performance, and clinical value is a complex challenge.
Their team helped us structure the technical file, identify gaps early, and make sure the clinical evaluation is aligned with regulatory expectations. This significantly reduced uncertainty and allowed us to schedule our audits with confidence.
For us, CE marking is not just a regulatory milestone. It’s what enables us to bring the product into clinical environments across Europe, and MedQAIR played an important role in helping us reach that stage in a structured way.
One of the most valuable aspects of working with MedQAIR was how they helped us navigate feedback on the technical file, especially around the clinical evaluation. They were very practical in identifying what the notified body would expect and how we should address the findings without overcomplicating the documentation.
They also helped streamline the communication with TÜV. Instead of going back and forth without clear direction, we were able to respond in a structured way and close open points faster.
That made a real difference for us as a startup.
Ivo played a key role during the technical review phase. He has a strong understanding of both the regulatory framework and how innovative products like AI-based medical software are evaluated.
His input helped us refine several parts of the documentation and prepare more effectively for the review discussions. Throughout the process, he remained incredibly pragmatic. Instead of theoretical guidance, he focused on actionable steps to move the review forward.
That combination of expertise and practicality made the process much smoother for our team.
For a startup, the challenge is balancing regulatory rigor with agility.
MedQAIR understood that context well. Their approach helped us build the processes required for ISO 13485 without introducing unnecessary complexity. They focused on what is essential and scalable, which is exactly what an early-stage medtech company needs.
It allowed us to establish a solid quality foundation without sacrificing our development speed.
Achieving CE marking is an important step for Synaptiq. It allows us to start deploying the product in European healthcare settings and gather real-world clinical experience.
At the same time, the work done around the technical documentation, clinical evaluation, and quality system also creates a strong basis for future regulatory pathways, including FDA.
The process with MedQAIR helped us build documentation and processes that are not just compliant for one milestone, but useful as we continue expanding internationally.
MedQAIR helped us translate a complex AI product into regulatory documentation that meets MDR expectations. Their support in structuring our Technical File, strengthening the Clinical Evaluation, and preparing us for notified body interactions gave us the confidence to move toward CE marking in a structured way. For a fast-moving startup like Synaptiq, that clarity and practicality made a real difference.
Synaptiq is a MedTech company developing AI-powered software for radiotherapy. Its Mediq RT software supports radiation oncologists and medical physicists by automating the contouring of organs at risk and clinical target volumes, helping reduce the time required for this stage of radiotherapy planning.
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