Matrix Requirements

Matrix Requirements is a comprehensive platform tailored for the medical device industry, focusing on Application Lifecycle Management (ALM) and Quality Management System (QMS) tools. This innovative software enables teams to manage the development lifecycle with enhanced efficiency, ensuring regulatory compliance and facilitating collaboration among various departments. With features such as centralized requirements management, end-to-end traceability, and robust risk management aligned with ISO 14971, Matrix Requirements significantly reduces the complexity of compliance and quality assurance processes. The platform is designed to support software development teams alongside Risk Assessment/Quality Assurance (RA/QA) teams, streamlining operations and ensuring audit readiness.

The ALM module provides tools for verifying and validating products, ensuring that quality standards are met and maintained throughout the development process. It helps in managing design controls and mitigating risks, promoting a proactive approach to regulatory compliance. The QMS software connects engineering and quality teams, simplifying processes related to CAPAs, audits, and training, while offering guidance aligned with both EU and US regulations.

Trusted by over 200 medical device companies, Matrix Requirements facilitates faster innovation while maintaining the highest standards of quality and safety. Users can access a library of quality standards and pre-structured templates to assist in regulatory submissions. The platform also features a user-friendly interface that enhances collaboration and ensures that all stakeholders are kept informed throughout the development process.