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.

The challenge
Our solution

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