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Matrix One

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66 reviews
  • 4 profiles
  • 4 categories
Average star rating
4.3
Serving customers since
2013
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Matrix Req

66 reviews

Matrix Req is a global software leader helping innovative Medical Device companies remain focused on developing safer products faster. MatrixALM & MatrixQMS reduce the regulatory burden by bridging the gap between agile & compliance to ensure quality across the entire product lifecycle. Matrix Req is an EN ISO 13485:2016 and ISO/IEC 27001:2013 certified company. Visit www.matrixreq.com for information.

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Matrix Connect

0 reviews

Matrix Connect: Secure Cloud Connectivity Made for Medical Devices Matrix Connect is the purpose-built cloud connection platform crafted for medical device innovators. Designed to simplify the complexities of data, compliance, and scale, it enables you to centralize, visualize, and manage device data — so you can accelerate development, reduce regulatory risk, and stay audit-ready. Compliance First, Built-In Meet IEC 62304 requirements, HIPAA, GDPR, and other key regulations with ease. Matrix Connect operates under an ISO 13485 certified quality management system with HITRUST-grade controls — so your cloud infrastructure is secure and compliant from day one. Fast Deployment & Scalable Growth Go from idea to cloud-connected device in weeks, not months. Our platform scales with you — whether you're launching a pilot or rolling out globally — and handles growing volumes of data without sacrificing performance. Flexible & Configurable Custom dashboards, modular APIs, and integration tools let you tailor visualization, reporting, access permissions, branding, and workflows. Whether you need a custom UI or embedded analytics, we give you control. Developer-Friendly Tools Easily connect devices using our SDK or standards-based Web API. Real-time data streaming, secure storage, and cross-device compatibility ensure data flows reliably and is usable wherever you are. Actionable Insights & Data Control From remote patient monitoring to alert generation, Matrix Connect supports workflows that keep you responsive. Access controls, adaptive dashboards, and detailed analytics make it easy to see what matters and act fast — while ensuring data privacy and integrity. With Matrix Connect, your team can stop reinventing infrastructure and start driving medical device innovation. Focus on your devices, your patients, and your mission — we’ll handle the secure, compliant cloud connectivity that scales with you.

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Matrix Quality

0 reviews

All-in-one QMS solution managing compliance, quality, and operations Matrix Quality empowers organizations to streamline compliance, enhance collaboration, and accelerate innovation while maintaining regulatory rigor.

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Matrix eIFU

0 reviews

Matrix eIFU is a cloud-based electronic Instructions for Use (eIFU) solution for medical device and IVD companies. It enables organizations to deliver digital, regulatory-compliant instructions through branded websites, replacing paper-based distribution. Features include white-label customizable eIFU delivery, audit logs and version management, multi-language support, geo-fencing, ISO 9001 and ISO 27001 certified hosting, and pre-built QA documentation templates for software validation.

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Matrix One Reviews

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Profile Name
Star Rating
41
20
4
0
1
LZ
Lorrta Z.
09/08/2026
Validated Reviewer
Verified Current User
Review source: Organic

Very effective for verification and validation traceability

Matrix Req has made it much easier to connect requirements with test cases, test runs and V&V evidence. We can quickly identify missing verification coverage and understand which requirements are affected when something changes. That is a major improvement over manually maintaining a verification matrix.
Verified User in Medical Devices
UM
Verified User in Medical Devices
09/07/2026
Validated Reviewer
Verified Current User
Review source: Organic

Sleek, Lag-Free UI with Powerful Traceability and Customization

Traceability links, UI/UX is sleek and lag free, customisability to set markers and workspaces
Benoît B.
BB
Benoît B.
Senior regulatory project manager
09/07/2026
Validated Reviewer
Verified Current User
Review source: Organic
Translated Using AI

A Truly Effective Tool

Requirement-based approach, with a high level of customization. Compliant with ISO 13485 and AIAct proof.

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HQ Location:
Oberkirch, BW

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What is Matrix One?

Matrix One (previously Matrix Requirements) is a global software leader helping innovative Medical Device companies remain focused on developing safer products faster. Our software solutions include: - Matrix Req : AI-assisted design control & eQMS software that reduces the regulatory burden by bridging the gap between agile & compliance to ensure quality across the entire product lifecycle. - Matrix Connect (previously Galen Data): convenient, secure, compliant, cloud connectivity software purpose-built for medical devices. - Matrix Mind: AI-powered co-pilot for regulatory and quality teams helping them to supercharge compliance, reduce manual work, and stay ahead of global regulations

Details

Year Founded
2013