Matrix Quality for In Vitro Diagnostics (IVD)

IVD companies operating under IVDR and ISO 13485 face tight documentation, traceability, and post-market requirements. Matrix Quality provides the quality system infrastructure to meet them.

The challenge
Our solution

Common workflows

Quality processes designed for IVD manufacturers and developers.

Batch record managementElectronic batch records with full traceability from raw material receipt through production, QC release, and distribution.

  • Digital batch record documentation

  • Full lot and material traceability

  • QC release workflow with e-signatures

OOS and deviation managementHandle out-of-specification results and deviations with structured investigation workflows, root cause analysis, and direct links to CAPA.

  • OOS result investigation workflow

  • Deviation documentation and classification

  • Link to CAPA and change control

Complaint management and trend analysisManage customer complaints and post-market feedback with investigation workflows and trend reporting aligned to IVDR post-market surveillance requirements.

  • Complaint intake and investigation

  • Post-market surveillance data management

  • Trend analysis reporting

Regulatory submission trackingTrack product registrations, IVDR performance evaluations, and post-market performance follow-up (PMPF) across markets.

  • Product registration management

  • PMPF planning and documentation

  • Multi-market submission tracking

Hear from our customers

Roche

Matrix Quality gives us a single, validated system for our entire quality process. Audits that used to take weeks of preparation now take days.

Quality Director, Life Sciences Company

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