A Validated eIFU Service?

Manufacturers marketing product in the European Economic Area (EEA) must now complete registration in EUDAMED.

Manufacturers need to register the official URL where e-IFUs are hosted in the EU’s EUDAMED database.

EUDAMED eIFU Compliance – Service Provider Available

>QMS Velocity has an online form and partners with Shedpaper to provide a one-stop service.

>Robust software validation: Online Documentation Specification

>Example: Working eIFU Solution

Outsource the activity to a service provided that can be managed through existing supplier management controls. Added benefit: Risk management, software validation, and maintenance do not have to be recreated when the work has already been completed.

Implementation plan

Step 1: Add Shedpaper link to company webpage – Add the Shedpaper link to the company webpage.  Leverage Shedpaper software validation and risk management and perform periodic verification (a quality activity that is commonly performed).

Step 2: Update procedures-  Update labeling procedure to include a step to complete forms with the service.

Step 3: Update labeling – add eIFU symbol and labeling as required with the electronic IFU symbol per ISO15223 (eIFU symbol can be found https://www.iso.org/obp/ui/#home and enter ‘Electronic Instructions for Use’).  Transition IFU and labelling at a pace appropriate for the business.

Take advantage of a robust architecture with a secure and validated system developed specifically designed to manage documentation online.

Enabling online document management is available.

Try the link below and post online information:

eIFU and Online Documentation – QMS Velocity