Systems engineering

Systems engineering is defined as a methodical, multi-disciplinary approach for the design, realisation, 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.

At the heart of systems engineering is 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 sub-systems with well-defined boundaries and interfaces. By establishing a robust system architecture from the start, the risk of subsequent fundamental problems is reduced.

Modelling and simulation

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

Concurrent development of your sub-systems

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

Requirements management

We help you identify and specify requirements based on the needs of all of 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 sub-systems 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.

Our capabilities

We can deliver your medical device efficiently and effectively using a systems engineering approach. We can help with:

  • Systems requirements management
  • System risk management
  • System architecture and design
  • System modelling and simulation

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