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Software that human life depends on - Solwit | Software Development | Tests | Cloud Services

Software that human life depends on

scalable resources on demand

safety-critical
software

product compliance
with IEC 62304

scalable resources on demand

safety-critical software

product compliance
with IEC 62304

Important information

Sector:

IT solutions

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Our client is a company with 19 years of experience creating software for business. It has successfully completed hundreds of projects in the fields of automation, logistics, and business processes.

Challenge

Development of safety-critical embedded software for an insulin pump.

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 has been on the market for some time, but now it’s time for a new model.


In devices for the medical industry, safety and reliability are crucial. Our client therefore needed a partner with extensive experience in creating embedded software and would be able to design a safety-critical system. The product also had to meet Class C requirements as described in the IEC 62304 standard for medical device software. This was not the first such project for us.


We have built experience in projects of the highest safety requirements, for example safety critical software for the railway industry that ensures safety and logistics of train routes on railway tracks. This project successfully confirmed our ability to create software on which human life depends. In addition, we always work in accordance with industry-specific standards and, when required, we help in the certification of this software. This was the case with Voestalpine (read the case study).

Solution

Complete and reliable firmware.

The project started in 2018 and continues to this day. The project is implemented by one of our leading programmers, an expert in safety-critical software. His tasks include not only code development, but also work of a conceptual nature: designing solutions and proposing techniques, and tools to optimize work in the project.

Effect

Medical device compliant with Class C – the highest safety classification as defined in the IEC 62304 standard.

Our engineer works with the client’s design team on a permanent basis. The applied work methodologies ensure that the product is delivered in accordance with the highest safety classification as defined in the IEC 62304 standard for medical device software.

Technologies

Technologies

Medical standards (IEC 62304), C and C ++ languages, STM32 processors, Motor control, Sensor support, Touchscreen

Tools

Bitbucket, Jira, Git, Eclipse, IAR, Jenkins, Rhapsody, Google Test

Methodologies

Agile Scrum modified for compliance with medical standards

Business Model

Time & Material

Team

1 embedded developer

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