eIFU Change Control & Publishing in Matrix eIFU

A structured, validated change control process governs every update to your electronic Instructions for Use, from initiation to final publication.

The challenge
Our solution

Core capabilities

A governed, auditable path from change request to live publication.

Structured change workflowsEvery IFU update goes through a structured request and approval workflow.

  • User role separation for 4-eye change control

  • Multi-stage review with configurable approver roles

  • Full traceability from initiation to publication

Controlled publicationNew IFU versions only go live once all required approvals are complete.

  • Controlled publication gated on approval completion

  • Stakeholder notification on every update

  • Aligned to ISO 13485, EU MDR, and FDA 21 CFR requirements

Zero uncontrolled changesRemoves the possibility of an unreviewed IFU reaching the field.

  • Enforced approval workflow, no exceptions

  • Full audit trail of every review step

  • Reduces recall and compliance risk

Hear from our customers

Moving from paper to electronic IFU with Matrix eIFU was perfectly guided and supported. No more printing, shipping, or inventory of paper IFUs — and a significant financial benefit for our organisation.

Regulatory Affairs Manager, Leading orthopedic devices manufacturer in Switzerland

Matrix One is trusted by 500+ Life Sciences & Medical Device Companies