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Arrière plan 2

UDI and EUDAMED shouldn't keep you up at night.

Medical equipment manufacturers, agents (authorized representatives), system and supplies assemblers and importers: What if you finally had a partner who UNDERSTANDS your constraints?

Arrière plan 3

Are You Ready for the EUDAMED Deadline?

May 28, 2026 is tomorrow. Your medical devices must be registered in EUDAMED. Your labels must comply with MDR/IVDR 2017/745 and 2017/746. Your UDI-DI and GTIN codes must be perfect.

  • Consultants can charge exorbitant fees and leave you to deal with technical issues on your own.

  • Standard software overwhelms you with technical complexity, requiring you to fill out spreadsheets (high mental workload).

  • Organizations give you rules... but no concrete solutions.

EasyUDI = A network of experts + Personalized support + Industry-specific tools = Stress-free compliance

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Kevin Mandrick

PhD, MD and IVDM Project Manager, Regulatory Compliance Strategist, GS1, Eudamed, and UDI Expert

  • Linkedin
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Adrien Lemaire

Technical Director, Data Architect, EasyGS1, EasyEUDAMED, and EasyUDI Expert

  • Linkedin
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Wadie El Amrani

IT R&D Engineer and Operational Decision Support Tools for Compliance, EasyRegTech Expert

  • Linkedin
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EasyUDI agent

He works for you, isn't that great?

    Arrière plan 1

    Human and technical support: you are never alone

    1. French specialists who speak your language (MDR, IVDR, MDCG, PRRC, PCVRR, QARA)

    2. Intelligent assistants that work through and automate technical complexity for you

    3. Continuous availability: email, chat, and phone, depending on your chosen plan

    4. Clear, jargon-free explanations: we explain, we train, and we reassure you

    Arrière plan d'une solution Easy UDI
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    Without any prior experience in the UDI field, we were able, in record time, to obtain all our compliant documents and to take control, from A to Z, of simple tools to edit and create our labels on the eyewear packaging. Our partners and our representative in Switzerland were immediately reassured by this level of professionalism.

    Standardization and reliability for partners

    Fast – Professional – Reassuring

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    Before EasyUDI, managing GTINs, UDIs, and printing labels on our eyewear packaging was a real headache. Between GS1 compliance, EUDAMED registration, and setting up a fast printing system, we wasted a lot of time. Now everything is simplified, automated, and understandable. The interface is extremely user-friendly! A breath of fresh air for a small structure like ours.

    Simplified label and UDI management

    Intuitive – Automated – Liberating

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    We generated our first UDI packaging with EasyUDI. In record time, they responded to our urgency and gave us tips to easily generate compliant UDI identifiers and prepare our submission to EUDAMED without stress. The support team is responsive and helpful.

    Responsiveness and tailored support

    Fast – Helpful – Reassuring

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    I had never heard of UDIs or EUDAMED, and I must admit that IT is not my area of expertise. But the EasyUDI team provided me with empathetic and efficient support: creating my Eudamed account, GS1 registration, and generating labels for my resuscitation devices. Beyond the technical solution, a relationship of trust was established.

    Account creation and personal support

    Educational – Empathetic – Reliable

    Starter

    Mise en conformité guidée

    Vous rendre conforme sans vous perdre dans la réglementation.

    Commencer

    Pro

    Conformité pilotée

    Sécuriser votre conformité avec une méthode éprouvée et un accompagnement structuré.

    Choisir Pro

    Entreprise

    Excellence Totale

    Piloter votre conformité réglementaire comme un actif stratégique.

    Nous Contacter

    EUDAMED Manager
    All-in-One UDI Compliance Made Easy

    Centralize your SRN, Basic UDI, and UDI-DI data, reduce errors, and stay fully compliant with dashboards, reports, and audit trails—all in one place.

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    Register your devices in EUDAMED with confidence

    Centralize and automate submissions: SRN, Basic UDI, and UDI-DI. The smart assistant reduces complexity and prevents entry errors.

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    Visualize, control, share your data

    A clear dashboard to manage UDIs, generate Declarations of Conformity, track regulatory history, and securely share data across your systems and partners.

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    Stay compliant without the paperwork burden

    Benefit from complete document management, full audit trail, and priority support—focus on your products, not the administration.

    UDI Generator
    The Fastest Way to Create and Print UDIs

    Easily generate UDI-DI and UDI-PI, manage GTINs with GS1, and print compliant labels in one click—always accurate, always up to date.

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    Create your UDI with ease

    Register your devices and manage GTINs on GS1 effortlessly. EasyUDI automates UDI-DI / UDI-PI setup and packaging levels, saving you valuable time from day one. Compliant with GS1 code 128 and GS1-DataMatrix standards.

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    Ready-to-use compliant label Templates

    Pre-built label templates that meet GS1, UDI-DI/PI, and HRI/AIDC standards—ensuring compliance, avoiding audit flags, and preventing costly regulatory issues.

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    Generate and print labels in 1 click

    Instantly produce compliant labels with live preview. Upload your GTIN, Product Spreasheet data, and auto-generate hundreds of labels at once, with error checking, packaging-level configuration, and customizable A4 layouts (8/10/12 labels per sheet).

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