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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.

Matrix Quality
The challenge
Our solution

IVD compliance under IVDR and ISO 13485 demands a robust, traceable quality system

A validated eQMS built for the specific demands of IVD compliance

  • IVDR raises the bar for documentation and traceability

    • The EU IVDR introduced significantly more stringent requirements for IVD companies. Documentation, post-market surveillance, and performance evaluation must be comprehensive and traceable.

  • IVDR and ISO 13485 aligned workflows

    • Matrix Quality is pre-configured for the documentation, traceability, and post-market requirements of IVD companies — supporting both EU IVDR and FDA submissions.

  • Batch record management is critical

    • IVD manufacturing requires precise batch documentation with full lot traceability. Manual records introduce transcription errors and slow batch release.

  • Digital batch records with full traceability

    • Electronic batch records eliminate transcription errors and give you complete lot traceability from receipt to release.

  • OOS and deviation handling must be systematic

    • Out-of-specification results and deviations must be investigated, documented, and resolved in a way that satisfies regulators and notified bodies.

  • OOS and deviation management

    • Structured workflows for out-of-specification results and deviations ensure every issue is investigated, documented, and resolved with a full audit trail.

    The challenge

    IVD compliance under IVDR and ISO 13485 demands a robust, traceable quality system

  • IVDR raises the bar for documentation and traceability

    • The EU IVDR introduced significantly more stringent requirements for IVD companies. Documentation, post-market surveillance, and performance evaluation must be comprehensive and traceable.

  • Batch record management is critical

    • IVD manufacturing requires precise batch documentation with full lot traceability. Manual records introduce transcription errors and slow batch release.

  • OOS and deviation handling must be systematic

    • Out-of-specification results and deviations must be investigated, documented, and resolved in a way that satisfies regulators and notified bodies.

    Our solution

    A validated eQMS built for the specific demands of IVD compliance

  • IVDR and ISO 13485 aligned workflows

    • Matrix Quality is pre-configured for the documentation, traceability, and post-market requirements of IVD companies — supporting both EU IVDR and FDA submissions.

  • Digital batch records with full traceability

    • Electronic batch records eliminate transcription errors and give you complete lot traceability from receipt to release.

  • OOS and deviation management

    • Structured workflows for out-of-specification results and deviations ensure every issue is investigated, documented, and resolved with a full audit trail.

    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