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.
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The challenge
IVD compliance under IVDR and ISO 13485 demands a robust, traceable quality system
- IVDR raises the bar for documentation and traceabilityThe 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 criticalIVD manufacturing requires precise batch documentation with full lot traceability. Manual records introduce transcription errors and slow batch release.
- OOS and deviation handling must be systematicOut-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 workflowsMatrix 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 traceabilityElectronic batch records eliminate transcription errors and give you complete lot traceability from receipt to release.
- OOS and deviation managementStructured 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 management
Electronic 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 management
Handle 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 analysis
Manage 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 tracking
Track 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
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
