Matrix eIFU for FDA eLabeling (US)

A flexible, validated platform to meet current and emerging FDA eLabeling requirements as the FDA continues to modernise its labelling regulations.

The challenge
Our solution

How Matrix eIFU supports FDA eLabeling

Built for US manufacturers reducing paper labelling costs.

Part 11 compliant hostingHosting and access controls built to meet FDA electronic record expectations.

  • 21 CFR Part 11 compliant hosting and access controls

  • Stable, persistent eLabel URLs referenced on device packaging

  • Support for FDA UDI linkage via GUDID

Paper obligation coveredInternational paper-on-demand fulfilment keeps you compliant with FDA conditions.

  • International paper on demand fulfilment

  • Version control and audit trail for FDA record keeping

  • Documentation package to support computer system validation

Built for US manufacturersReduce paper labelling costs and improve supply chain flexibility.

  • Reduces paper labelling costs

  • Improves supply chain flexibility

  • Meets current FDA eLabeling guidance

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