Matrix Req vs Ketryx: The Complete MedTech Solution
Why settle for just documentation automation when you can have a full Design Control & eQMS platform? Matrix Req manages the entire product lifecycle — from requirements and design control, to risk management, V&V testing, CAPA, QMS procedures, and training.
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 Ketryx
Common frustrations with Ketryx
Teams evaluating Ketryx for complete medical device development consistently report the same limitations.
Requirements management made simple with Matrix Req
Managing Requirements, Risk & Traceability across the product lifecycle
Complete traceability, automated compliance & AI-powered efficiency.
Siloed requirements and fragmented documentation
Engineering, quality, regulatory affairs, and risk teams often store requirements in disconnected tools — documents, spreadsheets, Jira tickets — making it hard to keep information consistent. When one requirement changes, you are manually hunting down every affected test, risk, and specification.
Unified Requirements Repository
Capture, manage, and organise all requirements, design artifacts, and test cases in one secure system — natively, without depending on Jira or external tools. Every item is versioned, searchable, and auditable.
Regulatory complexity across jurisdictions
Medical devices must meet multiple global standards — FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, IEC 62304 — each demanding rigorous documentation, traceability, and audit evidence across the full design history.
Built-In Compliance with Global Standards
Pre-configured workflows and templates aligned with FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and IEC 62304. AI-powered compliance checking highlights gaps and suggests modifications against your chosen regulatory framework.
Traceability breakdowns across the lifecycle
Maintaining end-to-end traceability between design inputs, risks, design outputs, and V&V test results is mandatory. Any missed connections during design reviews or audits can trigger non-conformities and delay market entry.
True End-to-End Traceability
Link requirements to design outputs, risks, and V&V test results. Live trace reports show exactly who did what, when, and why — so you are always audit-ready and submission-ready, regardless of your DevOps toolchain.
Manual risk management and poor integration
Risk activities often live outside core development workflows, leading to manual updates, missed links between risks and requirements, and risk matrices that fall out of sync with the actual design state.
Integrated Risk Management
Plan, track, and mitigate risks with configurable ISO 14971-aligned templates. Risks link natively to requirements and test cases, ensuring every safety concern is documented, mitigated, and fully auditable.
Cumbersome design control and V&V processes
Design control requires robust linking of requirements to design outputs and V&V tests — but disconnected systems make test planning and audit trails inefficient and error-prone, especially for hardware or combination device teams.
Simplified Design Control & V&V
Define multi-layered verification and validation cycles, automatically track results, and connect them back to requirements — reducing errors while strengthening design history file (DHF) documentation.
Time-consuming audit preparation
Without automated traceability and centralised design history, preparing technical documentation for regulatory submissions (510(k), CE marking, PMA) requires weeks of manual compilation rather than a single-click export.
Ready-For-Audit Documentation
Generate professional documentation and trace tables directly from your live data. With built-in audit trails, e-signature support, and one-click DHF export, you accelerate inspections and certification submissions.
Collaboration gaps across cross-functional teams
Without a unified platform, engineering, QA, and regulatory affairs teams work in silos — leading to version mismatches, duplicated effort, delayed review cycles, and slower time to market.
Cross-Functional Collaboration
Matrix Req aligns engineering, quality, and regulatory teams on one platform. Automated workflows and shared dashboards keep everyone aligned — so decisions are faster, rework is reduced, and product launches are accelerated.
Managing Requirements, Risk & Traceability across the product lifecycle
Siloed requirements and fragmented documentation
Engineering, quality, regulatory affairs, and risk teams often store requirements in disconnected tools — documents, spreadsheets, Jira tickets — making it hard to keep information consistent. When one requirement changes, you are manually hunting down every affected test, risk, and specification.
Regulatory complexity across jurisdictions
Medical devices must meet multiple global standards — FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, IEC 62304 — each demanding rigorous documentation, traceability, and audit evidence across the full design history.
Traceability breakdowns across the lifecycle
Maintaining end-to-end traceability between design inputs, risks, design outputs, and V&V test results is mandatory. Any missed connections during design reviews or audits can trigger non-conformities and delay market entry.
Manual risk management and poor integration
Risk activities often live outside core development workflows, leading to manual updates, missed links between risks and requirements, and risk matrices that fall out of sync with the actual design state.
Cumbersome design control and V&V processes
Design control requires robust linking of requirements to design outputs and V&V tests — but disconnected systems make test planning and audit trails inefficient and error-prone, especially for hardware or combination device teams.
Time-consuming audit preparation
Without automated traceability and centralised design history, preparing technical documentation for regulatory submissions (510(k), CE marking, PMA) requires weeks of manual compilation rather than a single-click export.
Collaboration gaps across cross-functional teams
Without a unified platform, engineering, QA, and regulatory affairs teams work in silos — leading to version mismatches, duplicated effort, delayed review cycles, and slower time to market.
Complete traceability, automated compliance & AI-powered efficiency.
Unified Requirements Repository
Capture, manage, and organise all requirements, design artifacts, and test cases in one secure system — natively, without depending on Jira or external tools. Every item is versioned, searchable, and auditable.
Built-In Compliance with Global Standards
Pre-configured workflows and templates aligned with FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, and IEC 62304. AI-powered compliance checking highlights gaps and suggests modifications against your chosen regulatory framework.
True End-to-End Traceability
Link requirements to design outputs, risks, and V&V test results. Live trace reports show exactly who did what, when, and why — so you are always audit-ready and submission-ready, regardless of your DevOps toolchain.
Integrated Risk Management
Plan, track, and mitigate risks with configurable ISO 14971-aligned templates. Risks link natively to requirements and test cases, ensuring every safety concern is documented, mitigated, and fully auditable.
Simplified Design Control & V&V
Define multi-layered verification and validation cycles, automatically track results, and connect them back to requirements — reducing errors while strengthening design history file (DHF) documentation.
Ready-For-Audit Documentation
Generate professional documentation and trace tables directly from your live data. With built-in audit trails, e-signature support, and one-click DHF export, you accelerate inspections and certification submissions.
Cross-Functional Collaboration
Matrix Req aligns engineering, quality, and regulatory teams on one platform. Automated workflows and shared dashboards keep everyone aligned — so decisions are faster, rework is reduced, and product launches are accelerated.
See how Matrix Req stacks up against Ketryx across key capabilities.
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 Ketryx in 4 simple steps
We analyse your Ketryx configuration and connected toolchain, and map requirements, risks, and traces to Matrix Req.
Requirements, risks, tests, and traces 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.
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