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.
Software as a Medical Devices are at the heart of Matrix Requirements
Software as a Medical Device (SaMD) is at the heart of market innovation and encompasses various devices, from AI-driven diagnostic tools to telemedicine platforms or mobile apps paired to sensors. Whether stand-alone or integrated into another device, the quality of its design is a key factor in supporting medical performance and safety. 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, making it possible to address the following in a single product:
IEC 62304 Compliance Support: Matrix Requirements® supports compliance with IEC 62304, streamlining the development and maintenance of SaMD.
Class A, B, or C Software: you can effectively handle SaMD across all risk classifications (Class A, B, and C), ensuring comprehensive risk management and regulatory compliance.
Agile Methodology Compatibility: Matrix Requirements® seamlessly integrates with Agile practices, promoting flexibility and adaptability in SaMD development.
Software System Diversity: Whether your SaMD is an autonomous system or integrated within a larger medical device, our tool provides the necessary framework for efficient development and regulatory compliance.
Monitoring and Diagnostic Software: Matrix Requirements® tool is well-suited for monitoring and diagnostic software applications, ensuring that these critical SaMD solutions meet stringent regulatory and quality standards.
Hear from our customers
Matrix Requirements is super effective at handling the complex relationships between design objects, and its user-friendliness convinced us that we’d found the perfect fit for our quality and requirements management needs.”
Michael Strelow, Quality Manager, ViViRA
