Matrix Req vs Greenlight Guru: which ALM is right for you?
Matrix Req delivers regulatory compliance for medical devices with automated requirements management, real-time traceability, and AI-powered risk analysis. Get to market faster with compliance built in.
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This comparison is based on publicly available information and internal analysis as of March 2026. Features and capabilities may change over time. For the most accurate and up-to-date information, you can refer to the official website of Greenlight Guru
Common frustrations with Greenlight Guru
Teams evaluating Greenlight Guru for complete medical device development consistently report the same limitations.
QMS-first, not a complete ALM platform
Greenlight Guru is built primarily as a QMS solution, so teams needing full ALM capabilities will still rely on additional tools.
End-to-end traceability limited to QMS scope
Full item-level traceability from software requirements to V&V results requires additional integrations for SaMD teams.
AI assistant restricted to higher pricing tiers
AI-powered features like design control suggestions and risk generation are locked behind premium plans.
Not ISO 13485 certified as a vendor
Greenlight Guru does not hold vendor-level certification, a potential gap for companies whose auditors assess supplier quality systems.
Workflows less configurable than dedicated ALM platforms
Teams with complex, multi-product processes may find the configurability more limited than purpose-built ALM platforms.
SaMD traceability depends on DevOps integrations
Software-intensive device teams must rely on third-party integrations like Jira, adding configuration overhead rather than native management.
Requirements management made simple with Matrix Req
The challenge
Managing Requirements, Risk & Traceability across the product lifecycle
- Siloed requirements and fragmented documentationRequirements scattered across spreadsheets, documents, and Jira tickets make it hard to stay consistent and track changes across teams.
- Regulatory complexity across jurisdictionsMeeting FDA, EU MDR, ISO 13485, ISO 14971, and IEC 62304 simultaneously demands rigorous documentation and traceability across every market.
- Traceability breakdowns across the lifecycleAny gap between design inputs, risks, and V&V results can trigger non-conformities and delay market entry.
- Manual risk management and poor integrationRisk activities disconnected from development workflows lead to outdated risk matrices and missed links between risks and requirements.
- Cumbersome design control and V&V processesDisconnected systems make test planning and audit trails slow, inconsistent, and error-prone.
- Time-consuming audit preparationWithout centralised design history, preparing submission-ready documentation takes weeks of manual work.
- Collaboration gaps across cross-functional teamsSiloed teams lead to version mismatches, duplicated effort, and slower product launches.
Our solution
Complete traceability, automated compliance & AI-powered efficiency.
- Unified Requirements RepositoryAll requirements, user needs, and specifications in one place, automatically linked to owners and dependencies.
- Built-In Compliance with Global StandardsPre-configured workflows for FDA, EU MDR, ISO 13485, ISO 14971, and IEC 62304, with AI-powered gap checking.
- True End-to-End TraceabilityRequirements linked to design outputs, risks, and V&V results in real time, so you are always audit-ready.
- Integrated Risk ManagementISO 14971-aligned risk templates linked natively to requirements and test cases, fully auditable at every step.
- Simplified Design Control & V&VMulti-layered verification cycles tracked automatically and connected back to requirements for stronger DHF documentation.
- Ready-For-Audit DocumentationOne-click DHF export with built-in audit trails and e-signature support, ready for inspections and submissions.
- Cross-Functional CollaborationEngineering, quality, and regulatory teams aligned on one platform with automated workflows and shared dashboards.
See how Matrix One's specialised features deliver superior compliance automation.
Comparison based on publicly available product information from both vendors as of May 2026. Features and capabilities may change over time.
Switching is easy
Migrate from Greenlight Guru in 4 simple steps
We analyse your Greenlight Guru configuration — design controls, risk, QMS records — and map everything to Matrix Req.
Requirements, risks, design controls, and quality records migrated with full traceability and version history preserved.
Workflows, roles, and templates configured with IQ/OQ documentation ready for your CSV validation process.
Full onboarding with a dedicated Customer Success Manager from day one.
Thank you
A member of our team will be in contact within 48 hours.
See why Matrix One is the smarter choice
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