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Our Mission

Lower the regulatory barrier, unleash innovation

At Certeafiles, we believe compliance should no longer be a barrier to medical innovation.

Our mission is to support medical device manufacturers in fully managing their regulatory obligations, from the first technical file to post-market follow-up.

3 pillars guiding our actions

Simplify compliance

Simplify compliance

We design clear, practical tools tailored to real-world needs. Our goal: reduce regulatory complexity so you can focus on what matters: your products.

Support with rigor

Support with rigor

Audit, consulting, training: we stand by your side with precision, pedagogy, and responsiveness. Each support is personalized, aligned with your priorities and operational constraints.

Support responsible innovation

Support responsible innovation

We believe in demanding, transparent, and sustainable medical innovation. That's why we develop digital solutions that guarantee a high level of document quality and traceability.