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.
Therapeutic Devices are at the heart of Matrix Requirements
Therapeutic Devices are critical to patient care, delivering life-sustaining or condition-improving treatments across a wide range of clinical environments. From precision-controlled infusion pumps to advanced ventilators and dialysis machines, these devices demand uncompromising safety, reliability, and regulatory rigor. Matrix Requirements® is purpose-built to support the development of therapeutic technologies, offering an all-in-one solution that ensures efficiency, compliance, and confidence throughout the product lifecycle:
ISO 14971 and IEC 60601-1 Compliance Support: Easily align risk management and electrical safety standards within your development process, supporting global regulatory approval.
Embedded Software and Hardware Traceability: Link requirements, design, and test artifacts across complex systems combining hardware, firmware, and software.
Safety-Critical Functionality Support: Ensure high-risk functionalities (e.g., dosage control, respiratory support) are thoroughly verified, validated, and traceable.
Real-Time Collaboration: Facilitate cross-functional team alignment and streamlined reviews with tools designed for iterative development and change control in dynamic regulatory environments.
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
