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Several solutions for your MDR/IVDR & EUDAMED compliance and packaging labeling with UDI
Your MDR/IVDR compliance, centralized and effortlessly managed
Forget regulatory complexity. EasyUDI brings all your UDI data together in a single, structured space, ready to use from the very first weeks. You gain clarity, speed, and peace of mind—without having to master technical terminology.
No more juggling Excel files, emails, and portals. Everything is in one place.
EUDAMED managed for you, from A to Z—no XML, no hassle
EUDAMED is complex, demanding, and time-consuming. With EasyEUDAMED, our teams take care of all your submissions for you. You validate, we submit. Your data is always up to date, without you having to handle a single technical file.
You trust our experts. Your EUDAMED data is always compliant and up to date.
Your entire catalog at a glance—finally readable
View your entire medical device portfolio in clear views tailored to each use: hierarchical tree structure, spreadsheet view, or time-stamped audit log. Never lose track of data again.
Who changed what, when, and why? The answer is always just a click away.
GS1 standards automatically mastered, no learning required
GS1 standard codes are essential for the identification and traceability of your medical devices. EasyGS1 guarantees full compliance with international identification requirements, without you having to become an expert in coding.
Your GS1 codes are generated, validated, and synchronized. You can move forward with peace of mind.
Personalized, human support throughout your project
UDI compliance is not a project you have to tackle alone. With EasyONBOARDING, a dedicated team guides you step by step, at your own pace, and transfers expertise to you in a fully transparent manner.
You are never alone when it comes to regulations. We are there for you every step of the way.
Compliant labels generated automatically—in bulk or individually
UDI labeling is a regulatory requirement, but it doesn't have to be a headache. EasyLABEL fully automates the generation of your labels, whether for single-unit production or a complete batch, with or without connection to your manufacturing line.
Your labels are MDR/IVDR compliant and generated in just a few clicks. No technical expertise required.
Your UDI data verified in real time — zero errors before submission
Incorrect data in EUDAMED can block your registration or lead to costly compliance issues. EasyDATA automatically checks each piece of information against EUDAMED, GS1, MDR, and IVDR rules before submission.
No surprises when submitting. Your data is valid before it even reaches EUDAMED.
Master UDI: the solution dedicated to highly individualized devices
Some manufacturers produce custom medical devices, tailored to each patient or batch. EasyMUDI addresses this specific complexity with a structured approach to developing and implementing your Master UDI without risk of error.
Your catalog is complex. Your solution should be too—but not your daily routine.
Join the partners who already use EasyUDI.
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HOW IT WORKS
Automate every step, from your raw data to the creation of your enriched UDI database
ready for publication
on EUDAMED
Extraction & Enrichment
Say goodbye to time-consuming manual data collection
Our AI agent scans GS1, your website, your product catalog, and all technical documents made available to it to extract useful attributes and data about your medical devices. It categorizes your products into families, rates the reliability of each source, and completes the UDI records, prioritizing your official manufacturer data.
Organizing & Categorizing
Generation & Quality Control
Visualization & Automatic Publication
Upload to EUDAMED
30X faster with no effort
Once you have validated the content, the AI agent can automatically publish it for you in the UDI/Devices module on EUDAMED. Whether for quality management, compliance, or traceability, our UDI dashboard has you covered. All that's left for you to do is manage the UDI labels on your packaging.
BENEFITS
Savings and
quickly measurable gains
ADVANTAGES
Why manufacturers love using EasyUDI
The UDI data for medical devices is qualified by the AI agent. Only data that complies with MDR/IVDR regulations is retained.
Easy to use
Data compliance and UDI
AI transparency (sources)
Human support and transparency
Multilingual generation
Accelerated process
