NEW!!! Flexibility & configurability to the next level with 2.4. Learn more!

Get your medical device

faster.

Streamline every stage of the development lifecycle with a flexible solution built for SxMD. Efficiently manage design controls from requirements to compliance with end-to-end traceability to mitigate risk.

Matrix Requirements Is trusted by 200+ SxMD & Medical Device companies

Designed by Medical Device experts

Purpose-built software platform to help you scale, enhance your workflows, and ensure regulatory compliance.

Control
Control medical device design
Innovate faster with a flexible item-based approach to documentation designed to meet even the most complex SxMD product needs.
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Reach
Build a compliant ALM & QMS with confidence
Enhance quality management with full traceability from design input to output with a purpose-built software platform that enables a collaborative quality culture across all teams.
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Accelerate
Accelerate SxMD speed to market
Take charge of evolving design, quality, and regulatory requirements while empowering team autonomy and get your product on the front line faster.
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Connect
Connect to your essential tools
Ensure frictionless alignment between platforms with native integrations for Jira, GitLab, GitHub, Azure DevOps and more. Leverage our REST API to connect with all your tools.
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Bridging the gap between software development and regulatory compliance.

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The Matrix Requirements Platform

Our easy to use, flexible software platform allows all teams to quickly document requirements & become compliant

ALMMatrix ALM

Build regulated software with an agile application lifecycle management tool made for medical devices. Ensure compliance is never a barrier to innovation.

  • Easily capture all design inputs and outputs

  • Generate DHF & Technical Files with a few clicks

  • Traceability across requirements, specs, tests & risks

  • Compatible with IEC 62304, 62366, ISO 14971 and more!

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Matrix ALM
QMSMatrix QMS

Navigate the complex regulatory landscape with an intuitive and fully customizable quality management system (eQMS).

  • Ensure compliance and product quality

  • Quickly write, review, and publish your quality manual

  • Manage quality records like CAPAs, supplier, audits and more

  • Full traceability from standards to processes  

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Matrix QMS

The backbone of medical device design

200+Customers Worldwide
23Countries
5000+Active Monthly Users
6000+Monthly Document Downloads

Learn more from our customers

We are the SxMD solution of choice, helping accelerate speed to market & compliance at 200+ Medical Device companies worldwide

Cognoa

“With workflow automation we can import thousands of test cases from our third-party provider 95% faster than if we were performing the same work by hand.”

Jeff Miller, VP of Engineering

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Limbus AI

"With automation from MatrixALM, we reduced our human resource requirements by two full-time equivalents, while reducing regulatory timeline by 6 months"

Jon Giambattista, Director of Software

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Vipun Medical

“I think VIPUN Medical has easily saved six months by working with Matrix Requirements to create efficient digital workflows.”

Carl Van Lierde, VP Product Development

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Cognoa
Limbus AI
Vipun Medical