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Overview
Matrix Requirements is a specialized Application Lifecycle Management (ALM) tool engineered exclusively for Medical Device companies, transforming complex regulatory compliance into a competitive advantage. While some template integrations and updates are not straightforward, its strong audit management capabilities simplify high-stakes regulatory inspections.
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Starting Price
Custom
Matrix Requirements Specifications
Project Management
Business Intelligence
Compliance and Risk Management
Document management
What Is Matrix Requirements?
Matrix Requirements software offers a configurable, turn-key electronic Quality Management System (eQMS) and ALM solution, centralizing all design control and quality management activities for medical device development. This highly specialized platform helps businesses ensure compliance with global standards, including ISO 13485:2016 and FDA regulations. Matrix Requirements features such as automatic traceability across all development artifacts, from requirements to test results, enable teams to generate compliant Design History Files (DHF) with minimal manual effort.
Matrix Requirements Pricing
Matrix Requirements offers the following pricing plan:
- Team Plus: €710/month
- Company Plus: €1090/month
- Enterprise Plus: Starting from €2600
Disclaimer: The pricing is subject to change.
Matrix Requirements Integrations
The Matrix Requirements software supports integration with multiple systems and platforms, such as:
- Jira software
- GitHub
- GitLab
- Azure DevOps
- Confluence software
Who Is Matrix Requirements For?
Matrix Requirements is ideal for a wide range of industries and sectors, including:
- Medical device manufacturing
- Regulatory affairs (RA)
- Quality assurance (QA)
- Research and development teams
Is Matrix Requirements Right For You?
If your organization requires a purpose-built ALM and eQMS solution specifically for the demanding regulatory landscape of medical device development, Matrix Requirements is the ideal fit. Its niche focus on standards like ISO 14971 ensures deep functionality for managing product risk and audit preparation.
Still doubtful if Matrix Requirements is the right fit for you? Connect with our customer support staff at (661) 384-7070 for further guidance.
Matrix Requirements Features
The dedicated Test Module allows users to define detailed test cases efficiently. Testing activities can be strategically planned and executed across multiple cycles, ensuring thorough product verification and validation. This systematic approach confirms that the medical device meets all regulatory requirements and performance standards before release.
Accelerate development for Software as/in a Medical Device (SxMD) using structured, off-the-shelf eQMS templates. These audit-ready templates are pre-aligned with stringent EU and US regulatory standards, ensuring compliance from day one. This functionality drastically reduces the time and effort required to establish a fully compliant Quality Management System.
Maintain continuous audit readiness with live traceability verification, which actively monitors development artifacts. The user interface immediately indicates if an essential trace link is broken, missing, or has become outdated. This critical, real-time feedback ensures all requirements are connected to specifications and tests, preventing compliance gaps before an audit occurs.
All crucial design items, requirements, and quality records are organized and stored in a logical tree structure. This hierarchical system ensures that teams can easily navigate complex documentation sets and related artifacts. The structured data environment simplifies the management of intricate medical device files, providing streamlined access for efficient control.
Utilize robust search strings to efficiently locate any item across the entire repository of design controls and quality records. The full-text search capability instantly filters the complex item tree to display only matching items. This powerful indexing capability saves significant time during critical documentation reviews or high-stakes regulatory submission preparations.
