Matrix eIFU for Multi-market Manufacturers

One platform to manage IFU content across the EU, US, UK, Switzerland, Brazil, Japan, and beyond — centralising the complexity of different regulatory frameworks, languages, and formats.

The challenge
Our solution

How Matrix eIFU solves it

Built for manufacturers certified across more than one market.

One source of truthA single platform manages IFU content across every market you sell in.

  • Single platform for all markets

  • Market specific publication rules and language configuration

  • Regulatory reference library for EU, US, UK, Switzerland, Brazil, and Japan

Jurisdiction-aware UDI linkingUDI linking that understands the differences between regional identifier systems.

  • Jurisdiction aware UDI linking across EU UDI, FDA GUDID, and EUDAMED

  • Country specific paper on demand fulfilment workflows

  • Mitigation strategies for markets that do not accept eIFU exclusively

Change control that scalesOne update cascades correctly across every market version.

  • Centralised change control that cascades updates across markets

  • Eliminates the risk of out-of-sync IFU versions

  • Built for manufacturers certified in more than one market

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