Matrix Requirements Medical

Design, connect, and launch your medical device with our comprehensive, cloud-enabled, AI-powered solution. This platform is built to simplify design control, quality management, and cloud data connectivity, facilitating faster certification and global regulatory adherence for complex medical devices.

Our Software Suite includes:

• The best design control & eQMS software for medical device companies: Build regulated software with an agile application lifecycle management tool. Ensure compliance with a customizable quality management system (eQMS) module, compatible with IEC 62304, 62366, ISO 14971, and more. Key features include capturing design inputs/outputs, generating DHF & Technical Files, ensuring traceability, managing quality records (CAPAs, supplier, audits), and accelerating go-to-market with AI features.
• The all-in-one cloud connectivity solution for medical device companies: Centralize data and leverage cloud technologies with a configurable, scalable, and user-friendly platform. Focus on innovation without needing expertise in software design, data infrastructure, or cybersecurity. This solution allows for secure data collection and storage, visualization and analysis of patient/device data, and ensures FDA and global regulatory compliance (HIPAA/GDPR, ISO 13485:2016, HITRUST).
• The first AI chatbot dedicated to RA/QA specialists in the MedTech industry: Get immediate, trustworthy answers to complex regulatory questions. Stay updated with dynamic international regulations, prepare high-quality submission documents, respond to changes, and maintain audit readiness.

Matrix One is trusted by over 300 global medical device companies. Our customers report significant time savings and reduced resource requirements. For example, one VP of Engineering noted importing thousands of test cases 95% faster, while another Director of Software reduced regulatory timelines by 6 months and human resource needs by two full-time equivalents. The platform's automation and efficient digital workflows have helped companies save months on product development and cloud connectivity implementation.