Medical electrical and non-electrical equipment with Matrix Requirements.

Medical devices vary greatly in complexity, from basic hardware systems to intricate systems integrating software, hardware, and diverse physical, chemical, and logical processes. This complexity makes managing consistent requirements and interfaces between subsystems crucial to ensure overall system performance and safety. Matrix Requirements addresses these challenges by utilizing systems engineering principles and end-to-end traceability techniques, enabling:

• IEC 60601-1 Compliance: Matrix Requirements® can support compliance with IEC 60601-1, streamlining the development and maintenance of medical electrical and non-electrical equipment.

• Class I, II, and III Devices: you can effectively handle devices across all risk classifications (Class I, II, and III), ensuring comprehensive risk management and regulatory compliance.

• Requirements of systems Management: With the capacity to fully define personalized design categories, Matrix Requirements® can help you manage devices with several layers of requirements, manage full traceability and ease impact analysis along the different levels. The Compose module also allows you to include design elements from one project to the other to combine several projects and manage complex systems.

• Hardware and Software Lifecycle Management: Matrix Requirements® seamlessly integrates with both hardware and software modules development lifecycles, facilitating end-to-end traceability and efficient product development, while keeping compliance to the parent system requirements.

• Diverse Device Support: From imaging systems and portable devices to IVD devices, medical robots, implants, drug-device combination and hardware materials, Matrix Requirements® provides a versatile framework for managing the development and regulatory compliance of a wide range of medical products.