Our Digital Solution

Create your technical files faster, more easily, in full compliance

Certeafiles simplifies, structures, and automates the assembly of the technical file for the CE marking of your medical devices.

Our digital tool is designed with and for industry professionals, in response to their real-world challenges.

Your compliance, simplified

Thanks to artificial intelligence, quickly identify all applicable standards for your medical device.

Reduce errors, accelerate regulatory reviews, and gain peace of mind.

Visualize and track key development stages of your devices, directly integrating regulatory requirements at each phase.

Optimize your organization and anticipate bottlenecks.

Conduct your risk analyses according to ISO 14971 directly within the tool.

Structure your scenarios, assess your risks, and document each decision in a compliant format.

Automatically generate complete technical files structured according to notified body requirements.

Save valuable time for your CE submissions.

Request a free demo today and see how our solution can transform your regulatory workflow.