Design Control & eQMS made simple with Matrix Requirements software.
Control Medical Device design with an agile all-in-one Matrix Requirements solution. Easily manage technical documents, tests & risks to ensure audit readiness.
Accelerate time to market
Easy to use, flexible application lifecycle management software platform designed to bridge the gap between quality and compliance.
Streamline & Centralize Design Control Management
Build Medical Devices with end-to-end traceability from development to deployment across the entire product lifecycle.
Capture, document, and manage all design requirements, design outputs and verification/validation tests in a centralized repository making it easy for teams to access, review, and update them throughout the product lifecycle.
Eliminate process bottlenecks and foster communication and collaboration among design teams and quality assurance teams with automated notifications and workflows
Pass any audit, compliance, or regulatory inspection with live traceability that shows who did what, when, and why at an item-based granular level.
Supercharge product development while maintaining traceability by reusing items from existing projects, working on multiple product releases in parallel without impacting the main project, and maintaining traceability by pushing source project updates across to all your other projects.
Manage your risks according to ISO 14971
Build tailored risk documentation based on procedures fully configurable to meet any Medical Device need.
Ensure all risk-related activities are documented and traceable throughout the development processes by linking risks to requirements, design outputs, test cases, and issues reports.
Plan, execute, and track risk mitigation activities with dashboards that show detailed information for your risk matrix, as-well-as risk before mitigation and risk after mitigation statistics.
Create adaptable risk matrices that evaluate risk at multiple levels of detail to enhance project outcomes, regardless of the project or phase of software development.
Multi-layered verification and validation testing
Immerse your design process in robust, multi-layered verification and validation testing to confirm your product meets requirements and fulfills its intended purpose flawlessly.
Connect your DevOps toolkit to automate test executions and manage text scripts with unparalleled efficiency without compromising on quality.
Support compliance using an application lifecycle management (ALM) solution that tracks the entire V&V process with detailed reports and audit trails.
Reduce application development costs and time with early detection of issues through continuous integration, continuous delivery and testing with an ALM that tracks testing activities systematically.
Build your documentation in compliance with the processes
Generate documentation for existing design inputs and outputs from simple requirements to complex trace tables.
Create professional documents from scratch or utilize a wide array of existing templates to expedite the process. Both static and dynamic content can be seamlessly incorporated to produce tailored and informative documents.
Optimize the review and approval process by conveniently marking specific items with review flags, facilitating focused attention. Additionally, the ability to create comprehensive review packets streamlines the collation of relevant materials, simplifying collaboration and decision-making.
Ensure security and regulatory compliance by implementing electronic signature capabilities that adhere to stringent industry standards, including FDA 21 CFR Part 11.
Streamline the CAPA process
Streamline your CAPA process with a dedicated customizable item category and manage it with a preconfigured project.
Configure CAPA items to track
All relevant information and control your CAPA workflow.
Link CAPAs to non-conformities, complaints, audits, and design elements to establish traceability.
Use dashboards to track CAPA status and generate reports.
Publish QMS procedures & train each employee
Manage the process of creation, review, publication and training on the QMS documentation.
Build the QMS Documentation through a central hub for creating and managing all QMS documentation, including processes, work instructions, and associated risks.
Review and Publish using labels and dedicated review items. Once approved, publish the documents on the LiveQMS for easy access by employees.
Create and track training for any published QMS document, defining training questions and assigning trainees based on roles or groups. Get insights into training progress through a dedicated dashboard
Integrate with your mission-critical applications
Enable continuous deployment capabilities by connecting your software development tools with an ALM and eliminate error-prone manual processes across your product lifecycle management activities.
Native integrations with popular DevOps tools like Jira, GitHub, GitLab, Azure DevOps, and Confluence for code management, testing tools, and more.
Build your own with our REST API that has documentation for every part of the Matrix software so you can build a connection to your other tools.
Simplify processes with our SDK that makes it easier for developers to create their own applications and customizations and includes examples for custom Matrix extensions.
Hear from our customers
"With Matrix Requirements, we can generate PDF documents in the same format as before in a highly automated way, improving our team’s efficiency by an estimated 60%."
Hans-Jurgen Schneider, Project Manager
Core Matrix Requirements Features
Design & Launch your medical device on the market faster with our all Matrix Requirements software, the all in one Design Control & eQMS software made for Medical Devices Companies.
Request a demo