Medical Device Systems Engineering

Medical device systems engineering is the application of engineering principles to get multiple systems operating together in a manner that is safe and reliable.

What is Medical Device Systems Engineering?

Systems engineering is an interdisciplinary field of engineering that generally focuses on the design, integration, and management of complex, interconnected systems over their complete life cycles. Systems engineering covers design, realization, technical management, operations, and retirement of a system and incorporates hardware, software, equipment, facilities, personnel, processes, and procedures.

When systems engineering is applied to a system, the result is a combination of components that work in synergy to collectively perform a useful function. Systems engineering covers a broad range of technical and human-centric disciplines to ensure that all relevant aspects of a system are considered for integration.

As the demand for complex, portable medical devices grows, applying systems engineering principles to medical devices means that the development of these devices follow a holistic, organized, and deliberate method for identifying and reducing patient and business risks early in the process.

What does system engineering include?

The result of systems engineering is an arrangement of sub-systems that together fulfil a purpose the individual sub-systems do not. Therefore, the main elements that systems engineering looks at are risks, requirements, reliability, logistics, coordination of different teams, testing and evaluation, maintainability, development, implementation, and decommissioning. As a result of the range of relevant topics, systems engineering becomes more difficult when dealing with large or complex projects.

Systems engineering processes

The systems engineering processes are interdependent, and highly iterative and recursive and result in a validated set of requirements and a design that satisfies stakeholder expectations. There are four main processes:

  • Capture stakeholder expectations

  • Define clear and unambiguous technical requirements

  • Perform a logical decomposition to create architecture

  • Formulate design solutions

Who does medical device systems engineering?

Medical device systems engineers and medical device system engineering companies perform systems engineering of medical devices.

ArrowFast team of experts offer a range of Medical Device Systems Engineering services for small or large systems. Please contact us at to find out more.