Pharma, biotech, medtech and diagnostics

Matrix OneCompliance software for life sciences, powered by AI.

One company for the regulated work pharma, biotech, medtech and diagnostics teams do every day: requirements, quality, connected products and product information.

Built for the rules every life sciences team shares

GxP21 CFR Part 11EU Annex 11Data integrity (ALCOA+)Audit trails

For taking a demo with our team.

Requirements, risk and traceability

Matrix ReqTraceability that keeps itself current, from device to combination product.

Requirements, risks, specs and test cases connected in one place, for teams developing regulated products: medical devices, diagnostics, drug and device combination products and software.

Change one item and every affected risk, spec and test is flagged before the design review, not during the inspection.
Ask Matrix Mind about the project in plain language, and let the Compliance Checker test it against the standards you hold.

Design controls21 CFR Part 4ISO 14971IEC 62304EU MDR / IVDR

For a Matrix Req demo with our team.

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Electronic quality management

Matrix QualityYour QMS off paper and inspection ready in weeks.

Matrix Quality is the electronic quality management system for medical device and life sciences companies that have outgrown paper, Word, Excel and SharePoint/Google Workspace.

Deviations, OOS, CAPA, change control, document control, training, suppliers, complaints and audits, from more than 50 modules in one system.
Live in 2 to 6 weeks. Our team supports you in migrating your documents from paper, Word, SharePoint or Google Workspace.

GxP21 CFR Part 11EU Annex 11ISO 13485GAMP 5

From €10,000 a year500 life sciences companies worldwide

For a Matrix Quality demo with our team.

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Compliant cloud for product data

Matrix ConnectGet product data into a compliant cloud in weeks.

For teams shipping connected devices, drug delivery systems and AI health software who would rather not build and certify the cloud themselves.

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.
Real world data from products in patients' hands, for adherence, performance and post market surveillance.

IEC 62304HIPAAGDPREU MDR

For a Matrix Connect demo with our team.

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Digital product information

Matrix eIFURetire the paper insert.

Clinicians, lab staff and patients scan and get the current instructions in their own language. Built for regulatory and labelling teams.

A hosted eIFU portal, ready off the shelf, 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 2021/2226EU MDRIVDR

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The Matrix One platform

One platform, five products

Matrix Req

Design control and risk management software for medical device and regulated product teams.

Features

AI-enhanced Design Control
AI-supported Risk Management
Technical Documentation
Integrations
Matrix Mind
Compliance Checker

Built for

Software as a Medical DeviceMedical Imaging and AIIn Vitro DiagnosticsDiagnostic EquipmentTherapeutic DevicesCardiovascular DevicesSee all 11 industries →

Explore Matrix Req →Get a demo

Agentic AI, built into the platform

AI that does the groundwork, with a person in charge

Across Matrix One, AI works on your live records, not on copies pasted into a chatbot. It finds what is missing, drafts the next step and hands every decision to a qualified person.

Ask in plain languageGet answers grounded in your own data, with links to the records they came from.

Check against the standards you holdGaps are flagged and sent to your review, not fixed behind your back.

Draft the routine workProposed changes arrive as redlines you can apply, edit or reject.

Keep the audit trailEvery applied change records who approved it and why.

See AI at Matrix One →

The closed loop

From a gap to a fix, with a person in charge at every step.

AI spots a gapA missing link, an open item, an outdated record
AI
AI drafts the fixProposed as a redline, from your live data
AI
A person reviews itApply one change, or apply all
Human
Applied with that person's permissionsThe reason lands in the audit trail
Human
Undo stays availableThe AI never deletes records
Safe

Zero data retention with every AI providerNo training on your dataYou own the output

Trusted by life sciences leaders

From global pharma to fast growing medtech

4.3/5

73 reviews on G2

4.8/5

on Capterra

5/5

on Google

500+

life sciences companies worldwide

“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 MillerVP of Engineering

“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'GradyCo-Founder and CEO

“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 GrangerSenior Marketing Officer

Matrix One in numbers