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eIFU

Admin Console & 4-Stage Release Workflow

Shared multi-SKU IFU mapping, 4-stage approval with self-approval block & hash-chain audit trail

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.