Diagnostic Equipment with Matrix Requirements®
As diagnostic technology evolves, so do the expectations for traceability, documentation, and compliance. Matrix Requirements® empowers development teams to meet these demands.
Diagnostic Equipment is at the heart of Matrix Requirements
Diagnostic Equipment plays a pivotal role in modern healthcare, encompassing everything from advanced imaging systems and in vitro diagnostic tools to essential laboratory instruments. The performance and safety of these devices rely heavily on precise engineering and rigorous adherence to regulatory standards. As diagnostic technology evolves, so do the expectations for traceability, documentation, and compliance. Matrix Requirements® empowers development teams to meet these demands, providing an integrated solution that supports the full lifecycle of diagnostic device design and regulatory approval:
IEC 60601-1 and IVDR Alignment Support: Matrix Requirements® supports documentation and quality processes in line with IEC 60601-1 and In Vitro Diagnostic Regulations (IVDR), ensuring readiness for audits and market entry.
Complex System Support: Whether managing multi-modal imaging systems or compact point-of-care devices, our platform ensures traceability across hardware, software, and reagent components.
Verification and Validation Management: Streamline V&V workflows with traceable test management that aligns with clinical performance and safety goals.
Efficient Change Control: Maintain control over evolving requirements and designs with integrated change management that supports continuous improvement and regulatory compliance.
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
