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.

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.

• 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.