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.
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The challenge
Uncontrolled IFU changes are a serious compliance and patient safety risk
- A wrong IFU in the field is a real riskAn outdated or incorrect IFU can lead to patient harm, regulatory action, or a recall.
- Approvals get skipped under pressureWithout an enforced workflow, urgent changes can bypass proper review.
- Traceability gaps are hard to explainAuditors expect to see exactly who approved what, and when.
Our solution
Every IFU change reviewed, approved, and published in a traceable, repeatable way
- 4-eye change controlRole separation ensures no single person can both make and approve a change.
- Multi-stage reviewConfigurable approver roles enforce the review process your quality system requires.
- Controlled publicationNew versions only go live once every required approval is complete.
Core capabilities
A governed, auditable path from change request to live publication.
Structured change workflows
Every 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 publication
New 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 changes
Removes 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
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