Matrix One
Matrix One is a private, PE-backed German SaaS company that provides an integrated cloud platform — covering requirements, eQMS, eIFU, device cloud connectivity, and LIMS — to more than 500 medical device, biotech, pharma, and laboratory customers worldwide.
- Company typePrivate
- Founded2014
- HeadquartersOberkirch, Germany
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Matrix One does
Matrix One is a private German software company, headquartered in Kehl with operations in France, the United States, Switzerland, and Israel, that provides a cloud-based software suite for medical device, biotech, pharmaceutical, CRO/CDMO, and laboratory organizations. Its platform unifies requirements management and design control (Matrix Req, formerly Matrix Requirements), electronic quality management (Matrix Quality, formerly Simploud), medical device cloud connectivity (Matrix Connect, formerly Galen Data), electronic Instructions for Use management (Matrix eIFU, formerly Dokspot), and a laboratory information management system (Matrix LIMS), with native bi-directional integrations into Jira, Azure DevOps, GitHub, GitLab, Confluence, and major ERP/CRM/EHR systems. The company sells exclusively through direct enterprise and inside-sales motions on annual SaaS subscriptions with bespoke pricing tied to users, product lines, and product selection, targeting more than 500 life sciences customers including Roche, Sanofi, Mindmaze, Meril, Diabeloop, and Vipun Medical.
The technical core combines a Salesforce-built eQMS layer with a standards-based SDK and web API for device connectivity, and embeds an AI assistant (Matrix Mind) and AI Compliance Checker for documentation navigation, requirements/risk/test-case generation, and regulatory gap analysis running in a zero-data-retention, siloed environment. The platform is independently certified to ISO 13485:2016, ISO/IEC 27001:2022, ISO 9001:2015, and HITRUST CSF, and is positioned for compliance with FDA 21 CFR Part 11, EU MDR, HIPAA, GDPR, and GxP. Founded in 2013/2014, the company (formerly Matrix Requirements) was acquired by Lauxera Capital Partners in 2022, rebranded to Matrix One in 2025, and has since executed three acquisitions — Galen Data (2024), Dokspot (2025), and Simploud (2026) — to assemble a full MedTech compliance and quality platform.
Matrix One firmographics
Firmographics- Name
- Matrix One
- Legal name
- Matrix Requirements GmbH
- Website
- https://matrixone.health
- Company type
- Private
- Founded year
- 2014
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Matrix One is a private, PE-backed German SaaS company that provides an integrated cloud platform — covering requirements, eQMS, eIFU, device cloud connectivity, and LIMS — to more than 500 medical device, biotech, pharma, and laboratory customers worldwide.
- Ownership category
- akta.pro rank
Matrix One industry classification
Industry- Product category
- Life Sciences Compliance and Quality Management Software
- NAICS
- Custom Computer Programming Services (541511), Computer Systems Design and Related Services (54151), Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services (518)
- SIC
- Services-Computer Programming, Data Processing, Etc. (7370)
- akta.pro primary industry
- Regulatory Information Management (RIM) & Submission Publishing Software (HLAGAJAL)
- akta.pro secondary industries
- Scientific Data Management & Data Platforms (SDMS/Data Lakehouse for R&D) (HLAGAJAC), Medical Device & IoT Security (Connected Devices/RPM/OT) (HLACAJAI)
Keywords
Where Matrix One is headquartered
LocationHeadquarters
- HQ city
- Oberkirch
- HQ country
- Germany
- HQ region
- Europe
Offices5 records
Markets served
Matrix One business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Infrastructure, Operations, Others
Revenue model
- SaaS Subscription: Annual subscription-based revenue model for all products. Pricing is bespoke and tailored to team size and product selection. Includes software updates, cloud hosting, storage, and customer support with no hidden fees or per-feature add-ons.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Annual | Team tier at $920/month for 3 users with AI features, design reviews, and review workflows |
| Subscription | Annual | Company tier at $1,390/month includes eQMS with Procedure & SOP Management, CAPA, group management and training |
| Subscription | Annual | Enterprise tier starting at $3,390/month for 20 users with SSO, 2FA, and local hosting options |
| Per seat | Annual | Light User license at $15/month for view-only access |
| Per seat | Annual | Plus User license at $45/month for enhanced engagement |
| Per seat | Annual | Full User license at $90/month for quality process management |
| Per seat | Annual | Admin User license at $125/month for full system control |
| Subscription | Annual | Team plan at $540/month for 3 product lines with unlimited IFU documents |
| Subscription | Annual | Company plan at $1,290/month for 15 product lines |
| Subscription | Annual | Enterprise plan with custom pricing for large organizations |
| Usage-based | Monthly | Development Grade at $3,675/month with 500k API calls, 2GB bandwidth, 100GB storage |
| Usage-based | Monthly | Commercial Grade at $4,725/month with 1M API calls, 4GB bandwidth, 1000GB storage |
Go-to-market motion2 records
Distribution channels2 records
Marketing channels6 records
Matrix One product offering
Product offeringCore offering
Matrix One sells a cloud-based SaaS suite for life sciences and medical device companies, integrating AI-powered requirements management and design control (Matrix Req), electronic Quality Management Systems (Matrix Quality), medical device cloud connectivity (Matrix Connect), electronic Instructions for Use management (Matrix eIFU), and laboratory information management (Matrix LIMS). The platform is pre-configured for global medical device regulatory frameworks (FDA, EU MDR, ISO 13485, ISO 14971, GxP, 21 CFR Part 11) and is sold to Class II/III medical device manufacturers, biotech, pharma, CROs/CDMOs, and laboratories.
Product overview
Matrix One offers a unified, cloud-based software suite for life sciences and medical device companies, integrating five core products: Matrix Req (formerly Matrix Requirements) for AI-powered requirements management and design control; Matrix Quality (formerly Simploud) for cloud-based eQMS and quality event management; Matrix Connect (formerly Galen Data) for medical device cloud connectivity and IoT; Matrix eIFU (formerly Dokspot) for electronic Instructions for Use management and distribution; and Matrix LIMS for laboratory information management. The platform is built with AI-enabled features including Matrix Mind (AI chatbot) and an AI Compliance Checker, and is backed by Lauxera Capital Partners with offices in Germany, France, USA, Switzerland, and Israel.
Differentiator
Problem solved
Functional benefit
Brands
- Matrix Req: AI-powered design control and requirements management software for medical device companies; formerly known as Matrix Requirements.
- Matrix Quality
- Matrix Connect
- Matrix eIFU
Products and services
- Matrix Req AI-powered design control and requirements management software for medical device companies, enabling requirements traceability, risk management, and automated compliance with FDA, EU MDR, and ISO 13485 standards.
- Matrix Quality Cloud-based electronic Quality Management System (eQMS) built on Salesforce, providing pre-configured workflows for CAPA, change control, training, audits, and document management aligned with FDA 21 CFR Part 11, ISO 13485, and GxP standards.
- Matrix Connect All-in-one cloud connectivity platform for medical device companies, offering pre-built SDK and web API for device-to-cloud connectivity, real-time monitoring, and post-market surveillance with ISO 13485, HITRUST, HIPAA, and GDPR compliance.
- Matrix eIFU Cloud-based electronic Instructions for Use (eIFU) management and distribution solution, enabling medical device manufacturers to provide digital IFUs via branded websites with full audit readiness and compliance with EU MDR eIFU regulations.
- Matrix LIMS Laboratory Information Management System for managing all laboratory activities in one platform in a GxP-compliant way, incorporated into the Matrix One portfolio following the Simploud acquisition.
Quantifiable outcome
- 28% time saved when writing, validating, and preparing technical documentation and audits
- +4 more outcomes
Companies that use Matrix One
Customer profileNamed customers11 records
Segments4 records
Ideal customer profiles4 records
Matrix One technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- Yes
- API docs
- API detail
Core technology
AI maturity
App detail
Integration10 records
AI capability4 records
Feature5 records
Matrix One partnerships and signals
Strategic signalScale indicators4 records
Recent moves7 records
Expansion highlights6 records
Matrix One competitors and assessment
Company assessmentBroad incumbents
- Veeva Systems: Public cloud-software leader for life sciences, with Vault Quality, Vault RIM, and Vault Clinical directly competing with Matrix Req, Matrix Quality, and the regulatory product lines. Veeva is a much broader incumbent with a much larger R&D and sales footprint in pharma and MedTech.
- Siemens Polarion: Enterprise ALM and requirements management platform from Siemens, often deployed in regulated MedTech and automotive engineering organizations. Broad incumbent with deep integration into Siemens' Xcelerator portfolio, competing with Matrix Req for large engineering-led accounts.
Direct peers
- MasterControl: Long-standing direct competitor in eQMS, quality document control, design control, and regulatory compliance for medical device and life sciences companies. MasterControl targets the same Class II/III MedTech buyers as Matrix Quality and Matrix Req.
- Greenlight Guru: MedTech-focused eQMS and design control platform competing head-to-head with Matrix Quality and Matrix Req in the medical device market, particularly with startups and mid-market device manufacturers.
- Qualio: Cloud-native eQMS purpose-built for life sciences startups and mid-market companies, with similar GxP/ISO 13485 value proposition and target buyer (Series A to mid-market MedTech, biotech, and pharma) as Matrix One's smaller-customer segments.
- Arena Solutions (PTC): PLM and design control platform owned by PTC with strong penetration in regulated industries including medical devices, competing with Matrix Req on requirements management, traceability, and BOM/version control.
- Jama Software: Requirements management and traceability platform with a regulated-industries focus, including medical devices, automotive, and aerospace. Directly comparable to Matrix Req on requirements, risk, and V&V management.
- Aras Innovator: PLM and product engineering platform with a regulated-industries go-to-market, including medical device and defense. Competes with Matrix Req on requirements, design, and traceability for engineering-driven MedTech customers.
- ComplianceQuest: Next-generation QMS, EH&S, and supplier management suite built natively on Salesforce, directly comparable to Matrix Quality. Same architectural dependency (Salesforce) and overlapping target customer in regulated life sciences and MedTech.
Emerging players
- Dotmatics: Scientific R&D data management and informatics platform for life sciences, with growing footprint in lab informatics and connected R&D workflows. Adjacent to Matrix Connect and Matrix LIMS in serving life sciences data and lab operations.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights7 records
Customer concentration
Matrix One social profiles
Digital presenceMatrix One compliance and trust
Trust signalCompliance12 records
Matrix One financial estimates
Financial estimateRevenue estimate
Valuation estimate
Matrix One leadership team
Management profileNumber of profiles
Profiles4 records
Matrix One subsidiaries and ownership
Company hierarchySubsidiaries3 records
Matrix One funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Matrix One M&A and investment
M&A and investmentM&A3 records
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Matrix One
What does Matrix One do?
Matrix One sells a cloud-based SaaS suite for life sciences and medical device companies, integrating AI-powered requirements management and design control (Matrix Req), electronic Quality Management Systems (Matrix Quality), medical device cloud connectivity (Matrix Connect), electronic Instructions for Use management (Matrix eIFU), and laboratory information management (Matrix LIMS). The platform is pre-configured for global medical device regulatory frameworks (FDA, EU MDR, ISO 13485, ISO 14971, GxP, 21 CFR Part 11) and is sold to Class II/III medical device manufacturers, biotech, pharma, CROs/CDMOs, and laboratories.
Is Matrix One a public or private company?
Matrix One is a private company. It is classified as private equity controlled and is currently operating.
When was Matrix One founded?
Matrix One was founded in 2014. It employs 11 to 50 people.
Where is Matrix One based?
Matrix One is headquartered in Oberkirch, Germany, in the Europe region.
How does Matrix One make money?
One revenue line is on record: saaS Subscription.
Who are Matrix One's main competitors?
Broad incumbents on record are Veeva Systems and Siemens Polarion. Direct peers are MasterControl, Greenlight Guru, Qualio, Arena Solutions (PTC), Jama Software, Aras Innovator and ComplianceQuest. Dotmatics is listed as an emerging player.
Does Matrix One have an API?
Yes. Matrix Connect offers a native SDK and standards-based web API enabling device-to-cloud connectivity and integration with third-party systems and EHRs. Matrix Req supports bi-directional data synchronization with external tools. Matrix Quality can integrate with ERP and CRM systems via APIs and connectors. No standalone developer portal or public API documentation URL was found in the source material.
What industry is Matrix One in?
Matrix One's product category is Life Sciences Compliance and Quality Management Software. Its primary akta.pro industry code is HLAGAJAL, Regulatory Information Management (RIM) & Submission Publishing Software, with a secondary code of HLAGAJAC, Scientific Data Management & Data Platforms (SDMS/Data Lakehouse for R&D). Its NAICS code is 541511 and its SIC code is 7370.