CompareMatrix Requirements (Matrix One) vs Qualio
from $22k/yr
Matrix Req Team Plus + 10 Matrix Quality licences
Choose it if: You build software or software-heavy devices and need design controls, risk and test traceability tied to your QMS.
Watch out: A full QMS takes two products from Matrix One: Matrix Req, plus Matrix Quality, a Salesforce-based eQMS acquired in 2026 and priced separately.
est. $12–30k/yr
Estimate from 2019–2021 list prices; implementation fee extra
Choose it if: You're a growing device or combined device-and-pharma company that wants a QMS your whole team will actually use, with design controls linked to Jira and data hosted in the EU.
Watch out: Prices aren't published, every plan carries an implementation fee, and complaint handling, vigilance reporting and production records aren't dedicated features.
| Matrix Requirements (Matrix One) 7.5 | Qualio 6.8 | |
|---|---|---|
| Price and buying | ||
| AffordabilityHow we score affordabilityEstimated yearly cost for a 10-person team, including required fees. | 5.5 from $22k/yr Matrix Req Team Plus + 10 Matrix Quality licences | 5.5 est. $12–30k/yr Estimate from 2019–2021 list prices; implementation fee extra |
| Price transparencyHow we score price transparencyWhether the vendor publishes its prices on its own website. | 9.0 Public price lists Enterprise Plus quote-based; no mandatory fees | 2.0 No public prices Published until 2021; implementation fee not published |
| Try before you buyHow we score try before you buyWhether you can try the product yourself before talking to sales. | 8.5 Free trial Self-serve for Matrix Req; Matrix Quality on request | 5.0 No free trial Interactive tour and live demo |
| Contract and lock-inHow we score contract and lock-inMinimum term, whether you can take all your data with you at no extra cost, and other lock-in risks. | 7.0 Annual Export to XML, Excel and PDF; REST API | 8.0 Annual Terms defer to the order form; pricing page says annual. Export in PDF, XLSX and CSV; public API |
| EU data residencyHow we score eu data residencyWhether your data can be hosted in the EU, and how clearly that's documented. | 5.0 EU by customer location Matrix Req; no public DPA; Matrix Quality region undocumented | 10.0 EU (Dublin) Public DPA and subprocessor list |
| Budget predictabilityHow we score budget predictabilityHow well you can predict future bills: price-increase clauses, price history and the cost of adding users. | 7.0 No cap on price increases Matrix Req list prices up about 31% from 2023 to 2026 | 5.0 Renewal increases not capped No list prices since 2021; one user reports a hike |
| Product | ||
| Compliance coverageHow we score compliance coverageHow much of ISO 13485, FDA and EU MDR the system covers out of the box, based on its documentation. | 8.0 ISO 27001 (valid to Dec 2026), IQ/OQ/PQ package; no UDI or PMS features found | 7.0 No UDI or vigilance reporting features found |
| Design controls and traceabilityHow we score design controls and traceabilityHow well requirements, risks, tests and software lifecycle are linked, and whether the design history file is generated for you. | 10.0 Documented traceability; Jira, Git and Azure DevOps links | 9.0 Trace matrix generation; Jira included |
| UsabilityHow we score usabilityEase-of-use ratings from G2 or Capterra, adjusted for what users repeatedly report. | 8.0 8.4 / 10 on G2 Weighted across both products; score capped at 8 (review drive) | 8.0 9.0 / 10 on G2 663 ratings |
| Service | ||
| Support and onboardingHow we score support and onboardingSupport ratings from review sites, plus whether onboarding help is included in the price. | 8.0 9.4 / 10 on G2 Weighted across both products; score capped at 8 (review drive) | 8.0 9.1 / 10 on G2 561 ratings |
| Community sentimentHow we score community sentimentOverall review-site rating, adjusted for what independent users say in communities. | 8.0 4.3/5 (66 reviews) and 4.9/5 (18) on G2; capped at 8 (review drive) | 8.0 4.4/5 on G2 (781 reviews) |
| Time to go liveHow we score time to go liveHow long it usually takes until your team can work in the system, and whether templates are included. | 6.5 1–3 months Vendor statements conflict; templates on Company plan | 6.0 30–60 days Vendor estimate; 8-week onboarding; templates extra |
Scores are out of 10. The better side of each row is highlighted. How we score
| Matrix Requirements (Matrix One) | Qualio | |
|---|---|---|
| Built-in document editor | YesRich-text editor for items and generated documents | YesIn-app editor with co-editing; users report weaker formatting than Word |
| Edit in Word or Google Docs | Partly or add-onMatrix Quality only (Office 365, SharePoint/Google); Matrix Req imports Word but can't edit in it | Partly or add-onWord via OneDrive integration; Google Docs must be converted |
| SOP templates included | YesSxMD SOP and document templates on Company plans | NoSOP templates are a paid add-on (Content Pathways) |
| Jira or Git integration | YesJira, GitHub, GitLab and Azure DevOps | YesJira included; GitHub, GitLab, Azure DevOps via add-on |
| IEC 62304 software features | YesSoftware traceability and IEC 62304 templates | Not confirmed yetNo IEC 62304-specific features documented |
| Validation package included | YesValidation project with plans, tests and reports | YesCSA validation pack per release; cost not stated |
| Public API | YesDocumented REST API; Salesforce APIs for Matrix Quality | YesREST API with developer portal, Growth plan only |
| Single sign-on (SSO) | YesMatrix Req: Enterprise Plus only; Matrix Quality via Salesforce | YesEntra ID, Google and Okta |
| Supplier portal | YesMatrix Quality portal for supplier forms and SCARs | Not confirmed yetNo external supplier portal found |
| Training with quizzes | YesMultiple-choice training questions in Matrix Req | YesMultiple-choice assessments, 100% to pass |
| FDA MDR or EU vigilance reporting | Partly or add-onReportability assessment on a marketing page only | Not confirmed yetNo FDA MDR or EU vigilance reporting found |
| AI features | YesMatrix Mind, AI design tools, compliance checker | YesAI gap analysis; AI Copilot in closed beta |
| Clause | Requirement | Matrix Requirements (Matrix One) | Qualio |
|---|---|---|---|
| 4.2.4 | Control of documents | ||
| 4.2.5 | Control of records | ||
| 6.2 | Training and competence | ||
| 7.3 | Design and development | ||
| 7.3.9 | Change control | ||
| 7.4 | Supplier qualification and control | ||
| 7.5 | Production records (DMR/DHR) | ||
| UDI | UDI management (EU MDR, FDA) | ||
| 8.2.2 | Complaint handling | ||
| 8.2.3 | Regulatory reporting (FDA MDR, EU vigilance) | ||
| MDR 83 | Post-market surveillance | ||
| 8.2.4 | Internal audit | ||
| 8.3 | Nonconforming product | ||
| 8.5.2 | Corrective action (CAPA) | ||
| ISO 14971 | Risk management file | ||
| IEC 62304 | Software lifecycle | ||
| Part 11 | Electronic signatures |
We haven't written a verdict for this pair yet. The comparison above comes from our research on each system; the full reviews explain each score.