eIFU
eIFU Electronic IFU Platform
Managed subscription eIFU platform compliant with MFDS Article 22, FDA 21 CFR 801 & ISO 13485
COMING SOON
Leanabl eIFU (Electronic Instructions for Use)
Compliant multi-language electronic Instructions for Use (eIFU) publishing, UDI/QR routing, and version archiving under EU 2021/2226. Currently in development and coming soon.
FEATURES
01
Multi-Language eIFU Version Control & Country-Specific Distribution
02
UDI-DI / GS1 QR Code Routing & Historical Version Archiving
03
EU 2021/2226, FDA, and MFDS e-Labeling Compliance Controls
Make your medtech operations lean and scalable.
Tell us your device class and target markets. We will outline the optimal pathway, operational scope, timeline, and risk assessment.