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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.

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Matrix eIFU

The challenge

A fragmented IFU landscape across every market you sell in

  • Every market has its own rulesMDR, IVDR, FDA, MHRA, Swissmedic, Anvisa, and PMDA all set different requirements.
  • Languages multiply the workEach country or region can bring its own language requirement on top of regulatory differences.
  • Versions drift out of syncWithout a single source of truth, IFU versions across markets risk falling out of alignment.

Our solution

A single platform, one source of truth, for every market

  • One platform for all marketsA single source of truth for all IFU content across every jurisdiction.
  • Market-aware configurationPublication rules and language configuration set per market.
  • Cascading change controlUpdates cascade automatically across all market versions.

How Matrix eIFU solves it

Built for manufacturers certified across more than one market.

One source of truth

A 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 linking

UDI 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 scales

One 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

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