Accelerate development throughout the product lifecycle.

Fast track development with an agile approach to managing highly regulated medical device documentation, risk, V&V, and development.

Trusted by 200+ SxMD & Medical Device Companies

Unify your data, design, and teams

Bridge the gap between RA/QA and Developer teams with a software platform that gives visibility across projects, teams, and tasks in one place. 

Manage documentation in one place

Quickly generate reusable and auto-updating documents like design control documentation, test reports, traceability matrices, ISO 14971 risk assessments and more.

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Matrix ALM

Simplify compliant test management

Streamline V&V and keep teams aligned across platforms by integrating IT tools with robust native integrations and access to our REST API for added support.

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End-to-end Traceability 

Build a clear audit trail and demonstrate your risk-based approach to development in your next audit with end-to-end traceability across your design and development tools.

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Improve cross team relationships

Give RA/QA teams the information they need without adding to your workload in one centralized software SxMD platform and drive strong alignment. 

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Maximize design time with workflows

Develop faster and with confidence with IEC 62304 compliant workflows that alert you of missing or suspect items that need attention to ensure teams are working by the books.

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Efficient and collaborative change control

Quickly track and trace changes at any item level. Set up automatic alerts and workflows when there are changes that need to be reviewed and approved aligned with ISO 13485.

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Hear from our customers

“The integration between MatrixALM and GitLab makes it simpler for our developers to determine what each specification requires, and for designers to understand if and how a specification has been implemented – boosting the overall efficiency of our development process by 15%

Nathalie Bosschaerts, Product Development Manager, Gabi SmartCare