The client was working on launching a new version of the insulin pump – a device that is used to treat diabetes and is designed to dispense insulin in precisely measured doses. This product had been on the market for some time, but it was time for a new model.
For devices used in the medical industry, safety and reliability are crucial. Therefore, our client required a partner with extensive experience in creating both embedded and safety-critical software. The product had to meet the Class C requirements as described in the IEC 62304 standard for medical device software. It was not our first project of this kind.
The project started in 2018 and lasted until 2019. It was led by one of our best software developers, an expert in safety-critical software. Apart from code development, he worked on designing the solutions, proposed techniques, and chose tools to optimize work within the project.
Our engineer worked as a full-time member of the client’s design team. The work methodologies devised at that time have ensured that the product is delivered under the highest safety classification as defined by the IEC 62304 standard for medical device software.
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