Your cart is currently empty!
Designed for
EU MDR 2017/745
Compliance
Comfortably build EU MDR Technical Documentation through easy-to-follow steps.
SAGE helps you meet Notified Body expectations to gain CE marking of your medical device.
We’ve dealt with the Notified Bodies.
So you dont have to.
SAGE simplifies the EU MDR
Compile With Clarity
Dynamic template which adjusts to
your device
Step-by-step compilation process
Focus on what is relevant to your device
Submit with Confidence
Developed by EU regulatory experts
Created using real-world feedback from
EU Notified Bodies and their expectations
Intelligent review module to flag potential gaps
before you submit
Maintain with Ease
Ongoing access to your documentation.
Templates updated with the latest gudiance and MDR requirements as they emerge
Word and PDF exports available for offline archiving
What makes SAGE different
Our goal is to empower innovative start-ups and enterprising small businesses. We want your devices to reach the patients that need them.
SAGE was created to remove the burden of regulatory hurdles and help you get to market as efficiently as possible.
With no ongoing subscriptions, you get lifetime access to a robust, compliant submission builder.
We’ve even built in templates for supporting documentation, and given you the ability to update the main template text to fully suit your needs.
Schedule a demo to see the full fucntionality and benefits that SAGE offers.
Pricing
SAGE AI
€1999
One-time cost. No subscriptions.
✓ 5 User accounts
✓ Dynamic MDR submission builder
✓ Walkthroughs for each section
✓ Exports to Word and PDF
Enterprise
.
Contact us for a custom solution
✓ Personalized templates and features
✓ Collaboration with RA experts
FAQs
Who is behind SAGE AI?
SAGE AI is a part of the wider Practial RA group. We have taken our expertise in developing training courses and consulting services and partnered with leading software developers in the United Kingdom to develop the SAGE platform. As this is our own product, we have full control to improve and refine the product, based on feedback from both users and Notified Body reviewers. This ensures you always have access to the most recent and highest quality product at all times.
I’d like to get to get a free trial, how can I do that?
We currently do not offer a free version of SAGE. However, we are always availbale to schedule a live demo with one of our advisors, and are open to discussing flexible licensing arrangements to best suit your needs.
Are there any submission builders for other markets, like the US FDA?
Currently SAGE is only available for EU MDR Technical Documentation. However, our development pipeline includes several additional services and markets, including a US FDA 510(k) submission builder. This is expected to go live in Q2 2025.
Are there consulting services offered with SAGE AI?
The standard SAGE AI license does not include additional consulting support. We have created detailed guides and walkthroughs specific to each step of the process, intended to assist regulatory beginners through the compilation process. However, if you feel that personalized consulting support may be useful for you, we can offer a custom quote through the Enterprise service tailored specifically to your needs. Don’t hesitate to schedule a call with our advisors to learn more.