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Matrix Quality for Software as a Medical Device (SaMD)

SaMD companies need a quality system that moves at the pace of software. Matrix Quality is a validated, cloud-based eQMS that fits lean teams and fast release cycles — without cutting corners on compliance.

Matrix Quality
The challenge
Our solution

SaMD teams need a quality system that keeps up with agile development

A cloud-native eQMS that fits the pace and structure of SaMD development

  • QMS built for hardware does not fit software

    • Traditional quality management systems are designed around physical device manufacturing. SaMD teams need workflows that fit continuous delivery, cloud deployment, and frequent software updates.

  • Pre-configured for SaMD compliance

    • Matrix Quality supports ISO 13485, FDA 21 CFR Part 820, EU MDR, and IEC 62304 workflows out of the box — no customisation required to get started.

  • Small teams, high compliance burden

    • SaMD startups and scale-ups often have lean QA teams managing a broad compliance scope across ISO 13485, EU MDR, and IEC 62304.

  • Scalable from startup to enterprise

    • Start with the modules you need on day one. Add more as your team and product portfolio grow — without migrating to a new system.

  • Post-market surveillance is harder to automate

    • SaMD requires ongoing monitoring of software performance in real-world use — connecting post-market data back to quality processes is complex without the right system.

  • Connected to design control

    • Pair Matrix Quality with Matrix Req to connect your quality system to software requirements, risk management, and technical documentation in one platform.

    The challenge

    SaMD teams need a quality system that keeps up with agile development

  • QMS built for hardware does not fit software

    • Traditional quality management systems are designed around physical device manufacturing. SaMD teams need workflows that fit continuous delivery, cloud deployment, and frequent software updates.

  • Small teams, high compliance burden

    • SaMD startups and scale-ups often have lean QA teams managing a broad compliance scope across ISO 13485, EU MDR, and IEC 62304.

  • Post-market surveillance is harder to automate

    • SaMD requires ongoing monitoring of software performance in real-world use — connecting post-market data back to quality processes is complex without the right system.

    Our solution

    A cloud-native eQMS that fits the pace and structure of SaMD development

  • Pre-configured for SaMD compliance

    • Matrix Quality supports ISO 13485, FDA 21 CFR Part 820, EU MDR, and IEC 62304 workflows out of the box — no customisation required to get started.

  • Scalable from startup to enterprise

    • Start with the modules you need on day one. Add more as your team and product portfolio grow — without migrating to a new system.

  • Connected to design control

    • Pair Matrix Quality with Matrix Req to connect your quality system to software requirements, risk management, and technical documentation in one platform.

    Common workflows

    Quality processes built for SaMD teams.

    Controlled document and SOP managementManage quality system documentation with controlled approval workflows, version control, and electronic signatures — aligned to 21 CFR Part 11 and EU Annex 11.

    • Structured review and approval

    • Version control with full history

    • Electronic signature compliance

    Software change controlRoute all software changes through a documented review and approval process with impact assessment and audit trail.

    • Change request workflow

    • Impact assessment documentation

    • Full approval and closure audit trail

    Post-market surveillance and complaint handlingTrack customer complaints and post-market feedback with a structured investigation workflow linked to CAPA and change control.

    • Complaint intake and triage

    • Investigation and root cause analysis

    • Link to CAPA and change control

    Training for distributed teamsAssign training to remote and distributed teams, track completion, and maintain qualification evidence — all in one system.

    • Role-based training assignment

    • Completion tracking for distributed teams

    • Training matrix with real-time visibility

    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