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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
Verified User in Medical Devices
AM
Verified User in Medical Devices
09/03/2026
Validated Reviewer
Verified Current User
Review source: Organic
Translated Using AI

Intuitive, powerful, and fast: QMS tool with top traceability and service

Very intuitive use (user interfaces, functions) Powerful capabilities to cover the entire scope of a QMS (e.g., ISO 13485) in one tool Traceability and auditability at the highest level Option for complete custom configuration via Admin Client Extremely fast service and response times Helpful AI agents tailored specifically to the tool's use case Fair costs
Rahul F.
RF
Rahul F.
Regulatory Affairs Officer at Meril Life Sciences Pvt. Ltd.
09/02/2026
Validated Reviewer
Verified Current User
Review source: Seller invite
Incentivized Review

Very Efficient and Easy-to-use software to maintain QMS within an Organization.

Matrix Requirements is a well-designed QMS software that covers the full QMS scope, including audits, risk management, and the Design History File. I recently explored its risk management capabilities, and it’s impressive how much you can do with it. The “Copy whole folder/files” feature is a big help when handling multiple company QMS setups. We’ve also started the Jira integration with Matrix, and it looks good so far. Since we’re a large company with multiple verticals, the pricing feels quite feasible for us, and the ROI looks very strong. The Matrix team’s support is prompt and genuinely helpful; at any time, they resolve most queries within about two days. The recent AI-integrated features are also well built, and they seem to be pretty accurate.
Wolfgang W.
WW
Wolfgang W.
Leading QA/RA initiatives in healthcare and start-ups.
09/02/2026
Validated Reviewer
Verified Current User
Review source: Organic

Total Flexibility, Unlimited Projects, and Excellent Support

Total flexibility, no limits on projects, excellent customer support

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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