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.
For taking a demo with our team.
The challenge
Medical device quality management is too complex for spreadsheets and disconnected tools
- Multiple regulations, multiple requirementsISO 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 weeksWithout 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 foundationWhen 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 complianceEvery 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-readyDocument 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 dataMatrix 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 management
Manage 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 closure
Log 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 qualification
Qualify 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 control
Manage 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
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
