Let AI do the heavy lifting
Our EUDAMED agent on the Regnora platform helps you automate the most time-consuming part of the registration process. The agent platform is quality-assured and complies with the requirements of ISO 27001, GAMP, FDA CSA, and ISO 80002.
Here's how it works
- Upload relevant documentation or connect the platform to your document management system.
- The agent collects data from existing documentation, structures the information in accordance with EUDAMED’s requirements, and prepares the registration with full traceability to the source for each individual piece of data.
- Once the agent is finished, an expert can easily review and validate the information directly within the platform.
- Once the data has been reviewed and approved, an XML file is generated that can be uploaded directly to EUDAMED.
Full control throughout the entire process
You remain in control every step of the way. The agent prepares the registration, while people review and approve the results. Nothing is submitted without your approval, and you can always see exactly where each piece of information came from. If you need support, our regulatory experts are available throughout the entire process.
Faster registrations while maintaining quality
The result is a much faster and more efficient registration process, without compromising on quality or traceability. All data is handled securely, every piece of information can be traced back to its source, and the registration documentation is ready for the next step.
Would you like to see how it works in practice?
Curious about how the EUDAMED agent can streamline your registration process? Fill out the contact form, and we’ll tell you more and show you how the solution works with your own documentation.
We also help identify and implement other AI agents for compliance work, quality processes, and regulatory workflows. Contact us, and together we’ll explore the opportunities available for your business.