Consulting services
Overview
As European requirements for AI systems grow more stringent, regulatory readiness is becoming as critical as technological performance. Within the TEF-Health network, Median Technologies became the first SME to receive a TEF-Health service, engaging with Laboratoire national de métrologie et d'essais (LNE) to strengthen the robustness of its AI development processes.
Founded in 2002 and headquartered in Sophia Antipolis, with subsidiaries in the United States and Shanghai, Median Technologies employs around 230 people worldwide. Historically an oncology-focused imaging CRO, the company expanded its activities through its dedicated AI Business Unit, eyonis (formerly iBiopsy), which develops CE-marked (class IIb) AI-based medical device software addressing different types of cancer.
Against the backdrop of evolving European AI regulation, Median sought to assess and reinforce the quality of its AI/ML development and evaluation processes in view of future certification requirements.
Impact
Through TEF-Health, LNE conducted a structured assessment of Median’s AI system development process. The review was based on documentation such as conception files, risk analysis matrices and evaluation plans, and was complemented by in-depth meetings with the AI development team, structured similarly to a certification audit.
The resulting report synthesized the strengths and weaknesses of the existing process and identified areas where information or clarification was needed. Because the assessment is grounded in requirements expected to form part of future AI regulation, the service provides Median Technologies with concrete guidance to move toward certification readiness.
Rather than focusing on clinical validation, the intervention addressed a decisive layer of AI market access: the soundness, traceability and regulatory alignment of the development process itself.
The Challenge
Median Technologies operates in a highly regulated environment, developing CE-marked AI-based medical device software. With the increasing level of regulatory requirements for AI systems in Europe, the company aimed to test the quality of its internal processes and enhance their robustness in anticipation of future compliance expectations.
Following renewed contact within the TEF-Health framework and benefiting from the project’s support conditions, Median and LNE defined a service tailored to improving the company’s preparedness for upcoming certification demands.
The Solution
LNE’s service consisted of a detailed process assessment aligned with its 2021 AI process certification framework, adapted to Median’s specific context. After reviewing documentation and conducting structured discussions with the development team, LNE produced a report highlighting both solid practices and areas for improvement.
By anchoring the evaluation in requirements expected to shape future AI regulation, the service offers Median Technologies a structured pathway toward reinforcing its development processes and preparing for future certification steps.
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