3D laboratory Instrument Simulation

The client initially requested a 3D simulator to decrease the costs of the product development including both hardware and software development. The first release was monolithic, than moved to a modular architecture, which would allow better flexibility and easier integration of new features.

We gathered detailed requirements and information on how the laboratory device and robotic instrument operates in real-time from the client. Our team conducted an initial analysis, breaking down the requirements into specific tasks and creating detailed project estimates and prepared a comprehensive document with tasks, budget, and timelines, which was reviewed and approved by the client.

We broke down the functional requirements into smaller, manageable tasks with detailed specifications for development, testing, and documentation were created, ensuring full traceability in the project management system.

The 3D simulation was implemented using Unity3D, while most of the business logic was developed in C#. The modular architecture allowed us to easily add new features without affecting existing functionality.
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All stages of the simulator development adhered to the IEC 62304 standard, fully aligning our processes with those of the client. This integration allowed us to maintain a high level of consistency and compatibility, ensuring that our work seamlessly fit into the client’s existing development workflows.

Early releases focused on manual testing according to IEC 62304 standards. We later transitioned to automated testing using SpecFlow, which allowed us to define test scenarios in a human-readable format.
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Now we run over 2400 automated tests daily, covering regression testing and new functionalities. Manual tests are used for complex UI interactions, ensuring thorough test coverage.

We successfully integrated the simulator with Tecan’s control software in such a way that the control application cannot distinguish it from the real device.
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The integration process involved continuous testing and close feedback loops with the client.

Comprehensive documentation for each release was developed, compliant with IEC 62304 for Class A devices. This included verification documentation for each iteration.

Each release candidate was thoroughly tested, with all test cases verified. Once all tests passed, the build was merged into the main branch and published as a release candidate.

We confirmed the functionality and compliance of each release candidate through automated and manual tests. Verification reports were generated, detailing the scope, coverage, and results of all tests.

On the validation step we validated that each release candidate met the client’s requirements.

Finally, we officially deployed the validated release and continued to provide ongoing support, ensuring smooth operation and handling any future updates.