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.
For taking a demo with our team.
The challenge
SaMD teams need a quality system that keeps up with agile development
- QMS built for hardware does not fit softwareTraditional 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 burdenSaMD 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 automateSaMD 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 complianceMatrix 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 enterpriseStart 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 controlPair 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 management
Manage 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 control
Route 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 handling
Track 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 teams
Assign 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
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
