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Matrix Quality for Medical Device Manufacturers

A validated eQMS built for the full range of ISO 13485, FDA 21 CFR Part 820, and EU MDR quality system requirements — from document control and training to CAPA and change control.

Matrix Quality
The challenge
Our solution

Medical device quality management is too complex for spreadsheets and disconnected tools

A quality system built for medical device compliance — not adapted from a generic tool

  • Multiple regulations, multiple requirements

    • ISO 13485, FDA 21 CFR Part 820, EU MDR — each demands a structured, documented, and auditable quality system. Managing this across disconnected tools is a compliance risk.

  • Pre-structured for medtech compliance

    • Every quality process in Matrix Quality is structured around the requirements of ISO 13485, FDA 21 CFR Part 820, and EU MDR. Your team works in a compliant way from day one.

  • Audit preparation consumes weeks

    • Without a controlled system, gathering evidence for a notified body or FDA inspector means manually pulling documents from multiple locations.

  • Always audit-ready

    • Document control, training records, CAPA, change control, and supplier qualification are all managed in one validated system — so inspections are not a scramble.

  • Quality processes are a bottleneck, not a foundation

    • When quality management slows product development rather than supporting it, teams find workarounds — creating undocumented risk.

  • Connected to product data

    • Matrix Quality links directly with Matrix Req, so quality processes and product development stay aligned across the full device lifecycle.

    The challenge

    Medical device quality management is too complex for spreadsheets and disconnected tools

  • Multiple regulations, multiple requirements

    • ISO 13485, FDA 21 CFR Part 820, EU MDR — each demands a structured, documented, and auditable quality system. Managing this across disconnected tools is a compliance risk.

  • Audit preparation consumes weeks

    • Without a controlled system, gathering evidence for a notified body or FDA inspector means manually pulling documents from multiple locations.

  • Quality processes are a bottleneck, not a foundation

    • When quality management slows product development rather than supporting it, teams find workarounds — creating undocumented risk.

    Our solution

    A quality system built for medical device compliance — not adapted from a generic tool

  • Pre-structured for medtech compliance

    • Every quality process in Matrix Quality is structured around the requirements of ISO 13485, FDA 21 CFR Part 820, and EU MDR. Your team works in a compliant way from day one.

  • Always audit-ready

    • Document control, training records, CAPA, change control, and supplier qualification are all managed in one validated system — so inspections are not a scramble.

  • Connected to product data

    • Matrix Quality links directly with Matrix Req, so quality processes and product development stay aligned across the full device lifecycle.

    Common workflows

    The quality processes medical device manufacturers rely on most.

    Document and SOP managementManage controlled documents with structured review, approval, versioning, and release workflows aligned to ISO 13485 requirements.

    • Controlled review and approval

    • Automatic versioning and change history

    • Role-based access and e-signature support

    CAPA tracking and closureLog quality events, investigate root causes, and manage corrective and preventive actions with full traceability from event to closure.

    • Quality event logging and investigation

    • CAPA assignment and due date tracking

    • Closure evidence and audit trail

    Supplier qualificationQualify suppliers, manage requalification, and track performance — with a supplier portal for direct SCAR and questionnaire management.

    • Qualification and approval workflows

    • Supplier portal for direct collaboration

    • Audit scheduling and finding management

    Change controlManage all product and process changes through a structured review and approval process with impact assessment and full documentation.

    • Change request initiation and review

    • Impact assessment workflow

    • Approval with e-signatures and full audit trail

    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