Matrix Requirements (Matrix One) review

About the price: Published prices, Sep 2026: Matrix Req Team Plus (3 users, $920/month on the vendor's USD list; €710 on the EU page) plus 10 Matrix Quality Full licences at $90/month. Extra Matrix Req users €65/month. Optional $8,000 onboarding package.

What is Matrix Requirements?

Matrix Requirements was founded in 2014 in Kehl, Germany, and Lauxera Capital Partners backed it in 2022.¹ In May 2025 it joined Galen Data under a new name, Matrix One. Matrix One says it has more than 500 customers and five offices.¹²

For a medical device QMS, two Matrix One products matter:

• Matrix Req, formerly Matrix Requirements, is the design-control system for requirements, risks, tests and traceability.³ It also has a built-in QMS module with SOP, record, HR and CAPA projects.⁴
• Matrix Quality, formerly Simploud, is a Salesforce-based eQMS that came with the acquisition announced in January 2026.⁵⁶ It adds deviations, complaints, nonconformances, suppliers, audits, change control and batch records.⁶

This review scores the combination a device company would realistically buy for full QMS coverage: Matrix Req plus Matrix Quality. Matrix One says connectors between the two are deployed.⁶ Still, they are two systems on different platforms.

Who Matrix Requirements is for

The clearest fit is a 10–50 person device company whose product is software or software-heavy. Matrix Req’s help center documents configurable traceability rules, flags for outdated links, and issue linking to Jira, GitHub, GitLab and Azure DevOps.⁷⁸⁹ Its template package covers IEC 62304.¹⁰ Independent Reddit users describe running inputs, risks and test reports in one place, and choosing it to keep design control and QMS together.¹¹¹²

Hardware makers get design controls and, through Matrix Quality, supplier, complaint and nonconformance workflows.¹³¹⁴¹⁵ We found no documented DMR/DHR, UDI or post-market surveillance workflow in either help center.¹⁶¹⁷

Look elsewhere if you need one system for design and quality, or documented vigilance reporting.

Matrix Requirements pricing

Matrix Req’s product page lists three plans, checked 30 September 2026:¹⁸

• Team Plus: €710 per month including 3 users, with design reviews, review workflows and AI tools.
• Company Plus: €1,090 per month including 3 users. It adds the built-in eQMS for SOPs, CAPA and complaints, and training.
• Enterprise Plus: from €2,600 per month for 20 users, by quote. It adds single sign-on and 2FA, and local hosting options.

On every plan, extra read/write users cost €65 per month. Read-only users cost €13 per month on Team and Company, and nothing on Enterprise.¹⁸ The vendor’s USD list shows Team Plus at $920, Company Plus at $1,390 and Enterprise Plus at $3,390 per month.¹⁹

Matrix Quality costs $15, $45, $90 or $125 per user per month by licence type, with a $10,000 minimum annual deal.⁶²⁰ Its billing page says implementation, migration, validation and training are included.²¹

A 10-person device team would buy Matrix Req Team Plus for three engineers plus ten Matrix Quality licences. That comes to about $21.8k a year ($11,040 plus $10,800) at published prices.¹⁹⁶ Company Plus alone for ten users would be €18,540 a year (€13,080 plus seven extra users at €780 a year each).¹⁸ That option covers SOPs, CAPA and training, but not Matrix Quality’s supplier and audit workflows. Onboarding is optional: a “Comprehensive Onboarding package” costs $8,000.³ In 2025, onboarding was mandatory at €1,500–2,500, and extra users were €57 per month.²²

Features

Document control, records and training

Matrix Req’s QMS project holds processes and work instructions, which are published to a “LiveQMS” web view.⁴²³ Documents are signed with Part 11 e-signatures and locked as PDFs.²⁴ Publishing a changed SOP can create training tasks, completed with a read-and-understood button or multiple-choice questions.²⁵ Matrix Quality can also route documents through Office 365 for editing, which requires paid Office 365 accounts.²⁶ Matrix Req only imports Word files.²⁷

Design controls and risk

Traceability rules can be required or optional per category, and reports show broken or outdated links.⁷⁸ Design reviews are recorded as items.²⁸ The risk module supports configurable risk formulas and several risk categories.²⁹ FMEA tables can be exported to Excel or generated inside signed documents.³⁰ AI features include the Matrix Mind assistant and a compliance checker.³¹³²

CAPA, complaints and nonconformance

Matrix Req’s CAPA project documents root cause, effectiveness checks and signed closure.³³ A Matrix Quality webinar walks through complaint statuses, investigation and escalation to a quality event.¹⁴ Its knowledge base describes deviation and NCR workflows with linked CAPAs.¹⁵ Complaint “reportability assessment” is only mentioned on a marketing page.³⁴

Suppliers, audits and change control

A Matrix Quality recording shows supplier evaluation before activation, due-diligence forms and supplier corrective action requests (SCARs) in a supplier portal.¹³ An audit webinar covers audit plans with approval, audit execution and a findings module.³⁵ A formal change-request workflow appears only on a marketing page.³⁶

Software development (IEC 62304)

The SxMD template package covers IEC 62304, IEC 62366, ISO 13485, ISO 14971 and 21 CFR 820, on Company and Enterprise plans.¹⁰ Together with the Git and Jira integrations, this is the strongest part of the offering for SaMD teams.⁹

What users say

On G2 in September 2026, Matrix Req has 4.3/5 from 66 reviews, with ease of use at 8.1/10 and quality of support at 9.2/10.³⁷ Matrix Quality, still listed as Simploud, has 4.9/5 from 18 reviews, with ease of use at 9.3 and support at 9.9.³⁸ Capterra lists only 7 reviews for Matrix Req, at 4.7/5.³⁹

Most Matrix Req reviews on G2 arrived in two waves. Of the 66, about 39 are dated between mid-August and late September 2026, and G2 labels them as organic. About 24 are from 2023 and 2024, and G2 labels almost all of those as invited by the vendor and incentivized.⁴⁰ Because a large share of the ratings comes from these concentrated waves, which we treat as an organised review drive, our usability, support and sentiment scores are capped at 8 rather than taken at face value.

• Ease of use gets mixed reports. Some reviewers praise the interface: those quoted on the vendor’s page call it user-friendly and intuitive, and one G2 reviewer singles out its “user-friendly interface”.³³⁷ More report the opposite: five recent G2 reviewers describe a steep learning curve and a dated or off-putting interface.³⁷ One ties the learning curve to the tool’s flexibility: new users need time to understand object types, relationships and workflows.³⁷ A Reddit user also reports a rough UI in places, such as templates.⁴¹
• Templates and documents: G2 reviewers say setting up document templates takes upfront effort, one misses Word integration, and two mention occasional bugs or slowness.³⁷
• Support: users praise fast answers, for example next-day responses to bugs.⁴¹³
• Community: independent Reddit users who set up their eQMS in it, or switched to it from Jama, report good results.⁴²⁴³ One older post calls the price steep.⁴⁴

Most recent Reddit praise comes from an account that says it works for Matrix, so we left it out.⁴⁵

Security, hosting and validation

Matrix Req is certified to ISO/IEC 27001:2022 (certificate valid until 1 December 2026, subject to surveillance audits) and ISO 13485:2016, and Matrix Quality to ISO 9001:2015. The certificates page lists no SOC 2 report.⁴⁶⁴⁷

The public subprocessor list shows AWS and OVH hosting that depends on customer location, including European sites.⁴⁸ However, the hosting article names no region, and we found no public DPA.⁴⁹ Matrix Quality runs on Salesforce, and its data region isn’t documented.⁶ Single sign-on is supported in both products, though for Matrix Req only on Enterprise Plus.⁵⁰⁵¹¹⁸

Matrix Req ships a validation project with pre-written requirements, risks, test cases, and a plan and report.⁵² The pricing FAQ mentions IQ/OQ/PQ documentation.⁵³ Matrix Quality generates validation plans and runs test scripts electronically.⁵⁴

Buying and contract terms

• Trial: you can start a Matrix Req trial yourself, with all features and no credit card.⁵⁵ The manual describes it as 14 days, extendable.⁵⁶ Matrix Quality’s 15-day trial must be requested.²⁰ Live 30-minute demos are also available.⁵⁷
• Term: subscriptions are annual and auto-renew, and fees for the rest of the term stay due if you cancel early.⁵³⁵⁸ The terms allow monthly or yearly plans but leave the term to the order form, while the pricing page says Matrix One sells annual subscriptions only, so we score the term as annual.⁵⁸⁵³
• Export and API: Matrix Req exports to Excel, XML, PDF and Word, and offers a full project backup and a public REST API.⁵⁹⁶⁰ Matrix Quality has a scheduled Salesforce data export (format not stated) and Salesforce APIs.⁶¹⁶²
• Time to go live: the vendor contradicts itself. The pricing FAQ says most teams are live in 30 to 60 days, while the Matrix Req FAQ gives a typical timeline of 2–3 months.⁵³³
• Price increases: the terms let Matrix One raise its price list during a contract after giving notice. They set no cap, and if you keep using the product after the effective date, you’ve accepted the new fee; your only alternative is to terminate.⁵⁸ Matrix Req’s list prices rose by about 31–33% between September 2023 (Team €540, Company €820 per month) and 2026 (Team Plus €710, Company Plus €1,090).⁶³¹⁸ Matrix Quality’s per-licence rates haven’t changed since October 2025, but its minimum annual deal went from $7,500 to $10,000 in early 2026.⁶⁴²⁰ We found no statement on whether existing customers keep old prices.
• If the vendor closes or is sold: the terms don’t promise data return or escrow if Matrix One becomes insolvent, stops the service or changes owner.⁵⁸

Company and ownership

Matrix Req is sold by Matrix Requirements GmbH of Kehl, Germany (Freiburg local court, HRB 712907, registered April 2015).⁶⁵⁵⁸ In June 2022 the Paris private-equity firm Lauxera Capital Partners took a majority stake with an initial €10 million from its Lauxera Growth I fund. At the time, Lauxera described the company as consistently profitable.⁶⁶ Lauxera still lists it as a current growth buy-out holding.⁶⁷

Lauxera added Galen Data in November 2024, the group became Matrix One in May 2025, and it bought Simploud and dokspot in January 2026.⁶⁸¹⁶⁹ Since February 2024, none of the founders has been a managing director.⁶⁵ Balance sheets for 2022 and 2023 are filed; we couldn’t read the figures.⁶⁵

Verdict

Shortlist Matrix Req if you’re a software-led device company and traceability from requirements to risk to test is your hardest problem. The design-control side is well documented and comes with a validation package and a self-serve trial. The main reasons for caution: a full QMS means a second, recently acquired product with an undocumented hosting region, and the full setup costs about $22k a year for ten people.

Visit the Matrix Requirements (Matrix One) website (made by Matrix One (Matrix Requirements GmbH))