Lean IFU
Kill the Paper Manual. Go Lean.
Switch to e-Labeling (eIFU) compliant with EU 2021/2226. Provide patients with always-up-to-date instructions via QR code.
Dynamic QR Codes
One QR code for all markets. Smart routing directs users to their local language version automatically.
Version Control
Users can access current and historical versions. Changes are logged for audit trails.
Paper on Request
Built-in toll-free number and order form fulfillment to meet the 'paper copy upon request' regulation.
The e-Labeling Workflow
01
Upload PDF
Upload your IFU PDFs tailored for different languages or regions.
02
Generate QR
Download high-res vector QR codes to place on your device packaging or label.
03
Patient Access
Users scan the code and see a mobile-friendly, compliant viewer. No app download needed.
Platform Features
ComplianceEU Regulation 2021/2226
Uptime99.99% SLA Guaranteed
SecuritySSL/TLS Encryption
LanguagesAuto-detection + Manual Selection
Fulfillment7-day paper delivery network
AnalyticsScan location & frequency tracking
FAQ
Q. Can I use this for all devices?
A. Primarily for professional use devices and specific implantables under MDR. Check eligibility with us.
Q. What if the website goes down?
A. We have redundant servers and a backup offline mode guarantee.
Q. Is the URL permanent?
A. Yes, we guarantee the URL validity for the lifetime of the device plus 10 years.