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Matrix One

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27 reviews
  • 4 profiles
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4.2
Serving customers since
2013
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Matrix Req

27 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

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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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16
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Verified User in Medical Devices
UM
Verified User in Medical Devices
01/08/2024
Validated Reviewer
Verified Current User
Review source: Seller invite
Incentivized Review

Clean and straightforward

It is a great, clean way to organize all you're documentation
pierre g.
PG
pierre g.
QARA specialist chez Diabeloop
11/07/2023
Validated Reviewer
Verified Current User
Review source: Seller invite
Incentivized Review

The simplest and effective tool for traceability management Matrix Requirements

For our Technical File, we use MatrixRequirements, a comprehensive platform that integrates the management of requirements, tests, test runs, risks and associated documentation in the medical device field. MatrixRequirements has been designed with great flexibility in mind, offering the possibility of configuring every aspect according to the specific needs of each company. This adaptability makes it possible to create customized categories to manage items such as 62304-compliant checklists, or cybersecurity analyses including vulnerabilities, threats, assets, and risks. By using MatrixRequirements, companies can effectively structure their practices, fostering optimal collaboration between R&D and quality teams. The tool guarantees simple, intuitive traceability, eliminating the burden of old methods that required hours of tedious work on endless spreadsheets. MatrixRequirements transforms traceability into a powerful tool for identifying gaps, areas not covered by testing and missing elements. The tool offers an advanced search function with a user-friendly query language for rapid access to essential information. MatrixRequirements allows you to store your documents, and offers document review and signature functions, as well as the option of publishing them. What's more, it complies with ISO 27001 standards, guaranteeing the security of stored information. Although MatrixRequirements offers great flexibility for customization, this adaptability can create complexity for users. Thanks to the efficiency of our technical support team, with rapid, pertinent responses in English or French, these problems are quickly overcome. Last but not least, two essential features deserve a mention: branch management and the ability to assign labels to items to create product variants (e.g., for children, for adults, for the EU, for the USA, etc.). These features are easy to implement, and are particularly appealing to developers, as they enable them to manage documentation in the same way as their code, maintaining consistency between the two. What's more, MatrixRequirements integrates seamlessly with your existing tools such as JIRA, GitLab, GitHub, and Slack. All in all, this translates into considerable time savings, reduced risk of non-compliance, and a clear improvement in documentation quality compared to using simple word processors and spreadsheets.
Verified User in Medical Devices
TM
Verified User in Medical Devices
11/07/2023
Validated Reviewer
Verified Current User
Review source: Seller invite
Incentivized Review

Fast and organised

Easily Traceability, The easy to link the requierement with the use cases and their risks, and the spec with their tests...

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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

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Year Founded
2013