Trainings

CERTEAFILES SAS

Serres-Castet, France

Why Certeafiles? In the medical device sector, regulatory documentation has become a real barrier to innovation. Regulation (EU) 2017/745 imposes strict, complex, and ever-evolving requirements. The result: regulatory teams under pressure, scattered files, and slowed projects. We have experienced this reality from the inside, as auditors, consultants, and advisors to manufacturers. And we came to a conviction: it's time to rethink how compliance is managed. A solution designed by and for medical device stakeholders Certeafiles was born from this realization. Our goal: to enable companies to manage their technical files in a guided, simple, fast, and reliable way. We designed a digital tool conceived for the real needs of medical device manufacturers. But before writing a single line of code, we set up human support (audit, consulting, training) to help you navigate the regulation. What we bring An intuitive platform to create, track, and validate your technical files Personalized support to secure every step of CE marking A long-term vision: making compliance a lever, not an obstacle Certeafiles brings together regulatory expertise and digital innovation to support health sector stakeholders.