Matrix Req

73 reviews

Matrix Req is a global software leader helping innovative Medical Device companies remain focused on developing safer products faster. MatrixALM & MatrixQMS reduce the regulatory burden by bridging the gap between agile & compliance to ensure quality across the entire product lifecycle. Matrix Req is an EN ISO 13485:2016 and ISO/IEC 27001:2013 certified company. Visit www.matrixreq.com for information.

Matrix Quality

18 reviews

All-in-one QMS solution managing compliance, quality, and operations Matrix Quality empowers organizations to streamline compliance, enhance collaboration, and accelerate innovation while maintaining regulatory rigor.

Matrix Connect

0 reviews

Matrix Connect: Secure Cloud Connectivity Made for Medical Devices Matrix Connect is the purpose-built cloud connection platform crafted for medical device innovators. Designed to simplify the complexities of data, compliance, and scale, it enables you to centralize, visualize, and manage device data — so you can accelerate development, reduce regulatory risk, and stay audit-ready. Compliance First, Built-In Meet IEC 62304 requirements, HIPAA, GDPR, and other key regulations with ease. Matrix Connect operates under an ISO 13485 certified quality management system with HITRUST-grade controls — so your cloud infrastructure is secure and compliant from day one. Fast Deployment & Scalable Growth Go from idea to cloud-connected device in weeks, not months. Our platform scales with you — whether you're launching a pilot or rolling out globally — and handles growing volumes of data without sacrificing performance. Flexible & Configurable Custom dashboards, modular APIs, and integration tools let you tailor visualization, reporting, access permissions, branding, and workflows. Whether you need a custom UI or embedded analytics, we give you control. Developer-Friendly Tools Easily connect devices using our SDK or standards-based Web API. Real-time data streaming, secure storage, and cross-device compatibility ensure data flows reliably and is usable wherever you are. Actionable Insights & Data Control From remote patient monitoring to alert generation, Matrix Connect supports workflows that keep you responsive. Access controls, adaptive dashboards, and detailed analytics make it easy to see what matters and act fast — while ensuring data privacy and integrity. With Matrix Connect, your team can stop reinventing infrastructure and start driving medical device innovation. Focus on your devices, your patients, and your mission — we’ll handle the secure, compliant cloud connectivity that scales with you.

Matrix eIFU

0 reviews

Matrix eIFU is a cloud-based electronic Instructions for Use (eIFU) solution for medical device and IVD companies. It enables organizations to deliver digital, regulatory-compliant instructions through branded websites, replacing paper-based distribution. Features include white-label customizable eIFU delivery, audit logs and version management, multi-language support, geo-fencing, ISO 9001 and ISO 27001 certified hosting, and pre-built QA documentation templates for software validation.

Matrix Validate

0 reviews

Matrix Validate is computer system validation (CSV and CSA) software for mid-size pharma and biotech teams. It is traceability-first validation: user requirements, risks and tests live as structured, linked data, so every protocol tests the right things and gaps show up before an inspector finds them. Teams use Matrix Validate to: Write URS and functional specifications as structured requirements, with configurable item types and enforced trace rules. Assess risk in line with ICH Q9 and GAMP 5, and trace every risk to the tests that cover it. Draft test steps with built-in AI test generation, then review and approve them. AI drafts, people sign. Execute test scripts with contemporaneous evidence, and reuse test cases across systems and releases. Generate 21 CFR Part 11 compliant live documents and traceability matrices, ready for audits and inspections. Connect to Jira, Azure DevOps and GitLab out of the box. Matrix Validate is built for CSV teams validating configured and custom GxP systems (GAMP 5 categories 4 and 5) and helps them prepare for the revised EU GMP Annex 11. It is available as SaaS or on premise, runs on the proven Matrix Req engine, and is delivered by Matrix One, an ISO 13485 and ISO 27001 certified company.