The 'Paper Anchor' on Your Supply Chain
Printing, managing, and shipping physical Instructions for Use (IFUs) is costly, environmentally wasteful, and creates significant compliance risks when updates are needed.
Update Nightmare
Recalling products just to swap a paper manual due to a typo or minor update, creating massive logistical costs.
Sustainability Debt
Generating tons of paper waste for manuals that are often discarded, conflicting with corporate ESG goals.
Compliance Risk
Failing to meet EU Regulation 2021/2226 requirements for providing instructions electronically, jeopardizing market access.
The Leanabl Insight
Go digital. Update instantly. Stay compliant globally. An eIFU system transforms a static piece of paper into a dynamic, controlled, and cost-effective communication channel.
A Fully Validated eIFU Platform
We provide a secure, mobile-friendly, and always up-to-date portal for your users' instructions, fully compliant with global regulations.
Dynamic QR Codes
Generate unique, scannable codes for your device labels that link directly to the correct, version-controlled IFU.
Automated Version Control
The platform automatically archives past versions of your IFU, maintaining a full, auditable history of changes as required by law.
Multi-Language Support
Auto-detect the user's region to display the correct language or allow for easy toggling between multiple translations on a clean interface.
From Upload to User in Seconds
Upload PDF
Securely upload your approved PDF manual to our validated admin panel.
Generate QR Code
The system generates a unique QR code for you to place on your device labeling.
User Access
Users scan the code and instantly view the correct IFU on any device, no app required.
Your Complete e-Labeling Package
Patient Portal
A clean, mobile-first web portal for users to access IFUs. No app installation required.
Full Audit Trail
Complete logs of who uploaded, changed, and archived which document, and when.
Free Paper Copy Request
A built-in, compliant contact form for users to request a physical copy at no charge.
Built for MedTech Compliance
EU 2021/2226 Ready
Our platform is built from the ground up to meet all specific requirements for providing instructions for use in electronic form.
Validated & Secure
We provide a fully validated software solution with robust data privacy controls, compliant with GDPR and hosted on secure infrastructure.
Integrated Safety Notifications
Instantly push critical safety updates or field notices directly to the IFU landing page, ensuring immediate visibility for users.
相关资源
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UDI Implementation Guide for Korea and Global Markets
Korea's UDI system runs on Korean GS1 codes and ties to the MFDS database. A practical implementation guide aligned with FDA UDI and EU MDR EUDAMED requirements.
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Go Paperless. Go Global.
Reduce costs, improve compliance, and enhance user experience with a modern e-labeling platform.
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