Our Digital Solution
Create your technical files faster, more simply, 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.
A solution currently under development and coming soon.
Main features
Your compliance, simplified
Automatic standards identification with AI
Thanks to artificial intelligence, quickly identify all applicable standards for your medical device.
Reduce errors, accelerate regulatory reviews, and gain peace of mind.
Design stage supervision
Visualize and track key development stages of your devices, directly integrating regulatory requirements at each phase.
Optimize your organization and anticipate bottlenecks.
ISO 14971 risk analysis
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.
Automated technical files
Automatically generate complete technical files structured according to notified body requirements.
Save valuable time for your CE submissions.
Ready to simplify compliance?
Request a free demo today and see how our solution can transform your regulatory workflow.
What Certeafiles will change for you!
Discover the benefits of our solution for managing your technical files and compliance.
Cost reduction
Divide your regulatory consulting fees by three.
Optimized validation
Eliminate redundant entries and errors with our semi-automated validation for consistently coherent files.
Compliance from the start
Achieve compliance on the first submission to the notified body and maintain it throughout your products' lifecycle.
Centralized management
Manage your entire product catalog from a single intuitive interface.
Streamlined regulatory monitoring
Receive notifications for every regulatory update to stay compliant at all times.
Simplified documentation
Generate your technical documents easily, even for complex areas like biocompatibility, electrical safety, or EMC.