QA Documentation Package from Matrix eIFU

A comprehensive, ready-made QA documentation package to support your internal validation and regulatory compliance activities — no need to build vendor qualification documentation from scratch.

The challenge
Our solution

Core capabilities

Ready-made documentation that meets notified body and inspector expectations.

Validation documentation, ready to goSoftware validation documentation, including V&V protocols and reports, provided in full.

  • Software validation documentation (V&V protocols and reports)

  • Risk management documentation aligned with ISO 14971

  • Communication plans for platform changes

Supplier qualification supportDocumentation ready to support vendor approval within your own QMS.

  • Supplier qualification documentation for vendor approval

  • Security and infrastructure documentation

  • Data processing agreements for GDPR compliance

Faster time to complianceReduces the internal validation burden significantly.

  • Meets notified body and regulatory inspector expectations

  • Limits internal validation costs

  • Accelerates time to compliance

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