A Validated Hosting Environment for Matrix eIFU

A fully validated architecture and hosting environment built for GxP compliance, data integrity, and the regulatory expectations of EU MDR, FDA 21 CFR Part 11, and ISO 13485.

The challenge
Our solution

Core capabilities

A pre-validated environment that removes months of internal validation effort.

Regulatory-aligned complianceBuilt to meet 21 CFR Part 11, GAMP 5, and ISO 13485 expectations from day one.

  • 21 CFR Part 11 compliant application features

  • GAMP 5 category aligned software validation approach

  • Computer system validation blueprint and guidance

Enterprise-grade securityInformation security controls aligned to ISO 27001, tested regularly.

  • ISO 27001 aligned information security controls

  • Regular penetration testing and vulnerability assessments

  • EU based data residency

Resilient by designBuilt to keep your eIFU content available when it matters most.

  • Disaster recovery and business continuity protocols

  • Months of internal validation effort saved

  • Reduced notified body audit risk

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