Medical Device Engineering

What is Medical device engineering?

Medical device engineering is a stage in the lifecycle of the development of a medical device which determines how the product design will be implemented. It essentially ensures that the medical device meets all functionality, usability, safety and reliability objectives.

The design consists of a set of requirement specifications for an effective medical device that addresses all feature specifications for the device’s intended use, all applicable compliance requirements (regulatory and standards) as well as addressing the device’s usability and any necessary risk mitigation. The design essentially specifies the “what” aspects of the device, i.e. what it must do, what it must look like, what it must cost, what is its size and weight, etc.

Medical device engineering then takes the design and determines how the design can be made a reality. The requirements produced in the product design stage are translated into technical specifications (i.e. determination of technologies, materials, processes, detailed drawings, circuit board layouts, etc.) that describes a system that conforms to all requirements. These technical specifications are then used as the input for the manufacture/implementation stage.

The engineering aspects of medical device development can involve the production of prototypes and usually involves iterations with the product design team if a design requirement cannot be achieved as specified. It would also address verification (i.e. does the device do what the requirements say it should) and validation (i.e. does the device achieve its intended use).

How do you make a medical device?

In order to make a medical device, you need to follow the stages of medical device product development. These cover all aspects of medical device development including taking into account safety and regulatory requirements.

Depending on the risk class of your medical device and your target market, you may also need to establish a quality management system.

You can either do all of these in-house or partner with experts in medical device design and engineering. We invite you to read our blog post Pros and Cons of Outsourcing Medical Device Development.

Who does medical device engineering?

Medical device engineers or medical device engineering companies, e.g. ArrowFast and Cosylab, are responsible for the engineering aspects of medical device development.

What does a medical device engineer do?

Medical device engineers contribute to two parts of the medical device product development process: the design and engineering stages. They understand the nature of medical systems and have the wide range of expertise necessary to solve the problem of creating a medical device that does what it is supposed to and looks like it needs to.

What companies develop medical devices?

Many medical device design and engineering companies, e.g. ArrowFast, specialise in providing the services necessary to develop medical devices, from product definition, development, regulatory compliance, certification for different markets. Did you consider outsourcing the engineering part? Why not read a blog about many benefits to outsourcing engineering to experts.

Do you want to develop your own medical device?

We are medical device engineering specialists with years of experience, thus don’t hesitate to contact us at if you need someone to help you out with developing your medical device.

Do you need help with developing your medical device?

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