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Software solution for life sciences innovation

Matrix One makes your mission easier, so you can focus on improving the life of millions

Matrix One integrates requirements management, design control, eQMS, eIFU, cloud connectivity, and AI-powered compliance tools to help life science organizations build, launch, and support better and safer products

For taking a demo with our team.

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Trusted by 500+ highly regulated customers across the globe

The Matrix One platform

From the first requirement to the device in the field, on one platform.

Five products, one data model. Requirements feed the quality record, the quality record feeds what you ship and support. Start with the one that hurts most and add the rest when you are ready.

01Build it
Requirements, risk and design control
Matrix Req
02Prove it
Quality system, lab data, audit evidence
Matrix Quality · Matrix LIMS
03Run it
Connected devices, live documentation
Matrix Connect · Matrix eIFU
Matrix Reqformerly Matrix Requirements

Requirements, risk and design control

Requirements, risks, specs and test cases in one place, with traceability that keeps itself current.

Built for engineering, QA and regulatory teams shipping Class I to III devices.

  • One repository for requirements, design artifacts and test cases, versioned and searchable.
  • Change one item and every affected risk, spec and test is flagged before the design review, not during the audit.
  • Load your own regulatory checklist and the AI compliance checker marks the gaps.
  • FDA 21 CFR 820
  • EU MDR
  • ISO 13485
  • ISO 14971
  • IEC 62304
See what Matrix Req doesBook a 30-minute walkthrough

One change, every consequence

REQ-142Alarm volume at least 70 dBedited
RSK-018Alarm not heard in a noisy wardreview
SPC-076Audio driver specificationreview
TC-311Alarm audibility testre-run

Edit one requirement and Matrix Req marks the three downstream items that now need attention.

Matrix Qualityformerly Simploud

Electronic quality management

Documents, CAPAs, change control, training and audits on workflows that arrive validation-ready.

Built for quality and regulatory leaders who own the inspection.

  • Pre-configured workflows aligned to 21 CFR Part 11, ISO 13485 and GxP.
  • Every quality event in one record instead of four systems and a shared drive.
  • A risk-based approach that cuts the validation effort you carry yourself.
  • 21 CFR Part 11
  • ISO 13485
  • GxP
See what Matrix Quality doesBook a 30-minute walkthrough
Matrix Connectformerly Galen Data

Device-to-cloud connectivity

Get device data into a compliant cloud in weeks, without building the infrastructure yourself.

Built for engineering teams shipping connected devices.

  • A native SDK and a standards-based web API in place of months of custom build.
  • Runs on ISO 13485-certified infrastructure with HITRUST controls already in place.
  • Live device data for performance monitoring and post-market surveillance.
  • IEC 62304
  • HIPAA
  • GDPR
  • EU MDR
See what Matrix Connect doesBook a 30-minute walkthrough
Matrix eIFUformerly Dokspot

Electronic instructions for use

Retire the paper insert. Clinicians and patients scan and get the current IFU, in their language.

Built for regulatory and technical documentation teams.

  • A hosted, off-the-shelf eIFU portal at a cost you can put in a budget.
  • Every version and every access logged, so the audit trail is already written.
  • Regulatory and validation documentation supplied with the service.
  • EU 2021/2226
  • EU MDR
  • IVDR
See what Matrix eIFU doesBook a 30-minute walkthrough
Matrix LIMSformerly Simplab

Laboratory information management

Samples, tests and results tracked end to end, without the spreadsheet that only one person understands.

Built for QC, analytical and clinical laboratories.

  • Configurable off-the-shelf workflows that adapt without custom development.
  • Real-time dashboards on sample status, turnaround and bottlenecks.
  • Audit trails and electronic signatures built in, not bolted on.
  • 21 CFR Part 11
  • GxP
  • Data integrity
See what Matrix LIMS doesBook a 30-minute walkthrough

Learn more from our customers

Since our foundation in 2014, we have helped hundreds of Medical Devices Companies across their entire journey, from requirements management to product clearance and audit.

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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“With the Matrix Requirements solutions, all employees enjoy access to up-to-date information, helping us to manage regulatory activities effectively.”

Carl Van Lierde, VP Product Development

Read full story

“The time we saved was the most critical aspect of working with Matrix Connect. It would have been at least six months building cloud connectivity from scratch.”


Greg O'Grady - Co-Founder and CEO, Alimetry

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“On top of them having the best solution in the industry, with Matrix Connect, for me, it's the people. They have built trust with our team, I trust them, and that is invaluable for us.”


Emily Granger - Senior Marketing Officer, Delphi

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Cognoa
Limbus AI
Vipun Medical
28%
Time Saved
When writing, validating, and preparing technical documentation and audits.
91%
Customers feel more confident
During audits thanks to Matrix Req.
50%
Faster products launches
Customer brought their products to market sooner thanks to Matrix One.

Life science teams choose Matrix One because we turn regulatory complexity into a competitive edge. With automation, traceability, and AI-powered insight built in, you can focus less on documentation and more on discovery

Regulatory confidence

Regulatory confidence

Built with compliance at the core. Meet FDA, MDR, and global regulatory requirements with confidence.

Accelerate innovation

Accelerate innovation

Reduce time-to-market with streamlined workflows and automated compliance processes

Cross-functional collaboration

Cross-functional collaboration

Unite R&D, Quality, Regulatory, and Operations teams on one unified platform

Get in touch with a Matrix One expert and discover how we connect compliance and innovation, so you can move from idea to impact, faster.

For taking a demo with our team.