Matrix Req
FeaturedReviewedRequirements, risk and test management for ISO 13485 medical device teams
About Matrix Req
Matrix Req is an application lifecycle management platform for teams building medical devices and other regulated products. It holds requirements, risks, design controls, test cases and defects in one linked structure, so traceability is a property of the data rather than a document someone assembles the week before an audit.
The design history file is generated from live project data, so preparing for an audit becomes an export rather than a four week reconstruction. Teams work to ISO 13485, IEC 62304, ISO 14971 and FDA 21 CFR Part 820 and Part 11.
It connects to Jira, Azure DevOps, GitHub and GitLab, so engineers stay in their own tools while the regulatory record keeps itself current. Used by medical device manufacturers, diagnostics companies and contract developers.
Key features
- End to end traceability from requirement to risk to test result
- Design history file assembled continuously, not rebuilt before an audit
- Risk management structured to ISO 14971
- Jira, Azure DevOps, GitHub and GitLab integrations
- Electronic signatures and audit trail for 21 CFR Part 11
- Configurable templates for IEC 62304 and ISO 13485 projects
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