Version Control & Audit Trail in Matrix eIFU

Every change to an IFU document is tracked, timestamped, and traceable — giving manufacturers the regulatory confidence they need across the full product lifecycle.

The challenge
Our solution

Core capabilities

Full traceability on every IFU document, from first version to latest.

Full version historyEvery change to an IFU document is tracked with a timestamped change record.

  • Timestamped change records for every edit

  • Comparison view between IFU versions

  • Retention of historical versions per EU MDR and FDA requirements

Role-based approval workflowsNew IFU versions only go live once the required approvals are complete.

  • Configurable approval roles before publishing

  • Automatic archiving of superseded versions

  • Notification when versions are updated

Inspection-ready audit trailEvery action is logged and accessible for regulatory inspections and notified body audits.

  • Audit trail logs ready for inspection

  • Supports ISO 13485 and MDR technical file maintenance

  • Zero manual record keeping

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