Systems engineering

Systems engineering is defined as a methodical, multi-disciplinary approach for the design, realization, technical management, operations and retirement of a system. Many product developments benefit hugely from a systems engineering approach. By applying key principles throughout, we can deliver your medical device efficiently and effectively while supporting ongoing lifecycle management and continuous improvement.

Our systems engineering support is based on a multi-disciplinary approach. This is primarily because of the need to develop a safe and balanced design in the face of opposing interests and multiple, sometimes conflicting constraints. Our software, electronics, and mechanical engineers work closely with human factors and designers to ensure that broader implications of design decisions are always taken into account to deliver the best possible product.

System architecture

To establish the system architecture, we need to consider all elements based on functional and physical attributes. We then decompose it into subsystems with well-defined boundaries and interfaces. By establishing a robust system architecture from the start, the risk of subsequent fundamental problems is reduced.

Modeling and simulation

Math modeling and simulation of your system early on, even at a simple level, helps guide development before test data is available. As simulation complexity and the level of understanding increases, modeling supports subsequent optimization and troubleshooting.

Concurrent development of your subsystems

To enable the concurrent development of subsystems, including (if necessary) across numerous organizations, it is important to have clearly defined interfaces and boundaries. This approach allows us to independently verify each subsystem against self-contained requirements sets and potentially minimizes disruptive delays during the final integration of your device.

Requirements management

Our systems engineering experts help you identify and specify requirements, based on the needs of all your key stakeholders – including marketing, regulatory, clinical, manufacturing and your users – this ensures a balanced approach covering multiple perspectives.

We further break down your overall product requirements and allocate them to subsystems e.g. software, hardware, mechanical. We manage and update requirements across the whole system during the development life cycle using robust tools and processes, making sure that they stay in sync with your development.