Software as a Medical Device (SaMD) with Matrix Requirements®
SaMD design must meet stringent standards based on demanding processes, and in recent years, regulations surrounding technical documentation have become stricter. Matrix Requirements® fully addresses the challenges of this constrained design.
The challenge
Our solution
Core Features
Purpose-built capabilities for SaMD teams navigating regulatory complexity.
IEC 62304 Compliance SupportStreamline 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 ManagementHandle SaMD across all risk classifications in a single platform. Define classification-appropriate processes, documentation, and controls for each software system.
Agile Methodology CompatibilityWork 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 DiversityWhether 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 SoftwarePurpose-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
Matrix One is trusted by 500+ Life Sciences & Medical Device Companies
