Software as a Medical Device (SaMD) with Matrix Req
SaMD design must meet stringent standards based on demanding processes, and in recent years, regulations surrounding technical documentation have become stricter. Matrix Req fully addresses the challenges of this constrained design.
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The challenge
SaMD compliance is uniquely complex — and getting stricter
Software as a Medical Device spans a wide range of products: AI-powered diagnostic tools, telemedicine platforms, mobile apps paired to sensors, and more. Whether standalone or embedded in a larger device, SaMD must meet stringent standards under IEC 62304, EU MDR, FDA, and other regulations — and technical documentation requirements have only grown more demanding in recent years.
- Multiple standards to satisfySaMD teams must navigate IEC 62304, ISO 14971, and regional regulations simultaneously — across all software risk classifications.
- Agile development vs. regulatory rigorFast-paced SaMD development cycles are hard to reconcile with the structured documentation and traceability that regulators require.
- Diverse system complexityWhether standalone or integrated, SaMD requires a flexible framework that adapts to different architectures without losing compliance.
Our solution
One platform built for the full complexity of SaMD design
Matrix Req fully addresses the challenges of constrained SaMD design — supporting compliance, traceability, risk management, and documentation in a single platform. From Class A to Class C software, Matrix Req adapts to your classification, methodology, and system architecture.
- Stay compliantacross IEC 62304, ISO 14971, EU MDR, and FDA requirements — without switching tools.
- Move fastwith Agile-compatible workflows that maintain rigorous traceability at every sprint.
- Scale across complexityfrom standalone diagnostic software to embedded SaMD in larger medical devices.
Core Features
Purpose-built capabilities for SaMD teams navigating regulatory complexity.
IEC 62304 Compliance Support
Streamline development and maintenance of SaMD with built-in support for IEC 62304 — covering software lifecycle processes, documentation, and traceability requirements.
Class A, B & C Software Management
Handle SaMD across all risk classifications in a single platform. Define classification-appropriate processes, documentation, and controls for each software system.
Agile Methodology Compatibility
Work the way your team works. Matrix Req integrates seamlessly with Agile practices, enabling iterative development while maintaining the traceability and documentation regulators expect.
Software System Diversity
Whether your SaMD is standalone or integrated within a larger medical device, Matrix Req provides the flexible framework needed for efficient development and compliance across different system architectures.
Monitoring & Diagnostic Software
Purpose-built support for monitoring and diagnostic SaMD applications — ensuring these critical solutions meet the highest regulatory and quality standards.
Hear from our customers
With Matrix Req, we avoid all the challenges of using manual or custom-developed tools. Instead, we get a purpose-built solution that’s designed by medical device experts, enabling much faster ISO 13485 compliance.”
François Audéon, Chief Technology Officer
