Therapeutic Devices with Matrix Requirements®

Therapeutic devices demand uncompromising safety, reliability, and regulatory rigor. Matrix Requirements® is purpose-built to support the development of therapeutic technologies.

The challenge

Our solution

Core Features

Purpose-built capabilities for therapeutic device development teams.

ISO 14971 & IEC 60601-1 Compliance SupportAlign risk management and electrical safety standards within your development process. Matrix Req supports the structured workflows, documentation, and traceability these standards require for global regulatory approval.

Embedded Software & Hardware TraceabilityLink requirements, design, and test artifacts across complex systems combining hardware, firmware, and software — maintaining full traceability across all components in a single project.

Safety-Critical Functionality SupportEnsure high-risk functionalities — such as dosage control, alarm management, and respiratory support are thoroughly verified, validated, and traceable to their design inputs and risk controls.

Real-Time Cross-Functional CollaborationKeep engineering, quality, and regulatory teams aligned with shared project visibility, structured review workflows, and change control tools built for dynamic, regulated development environments.

Technical Documentation GenerationGenerate audit-ready design history files and technical documentation automatically from your live project data — in PDF, Word, or HTML — ready for regulatory submissions at any stage.

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