CE-Marked Laboratory Diagnostics Software Delivered in 7 Months

Customer

The Customer is a European manufacturer offering genetic screening kits for diagnostic laboratories.

Challenge

The Customer needed to develop software for diagnostic laboratories to accompany the screening kits they offered. Accompanying software was to automate processing of genetic screening tests in the laboratories and validate the tests quality. To deliver the solution, the Customer was looking for an ISO 13485 certified medical software development partner.

Solution

The Customer commissioned ScienceSoft to develop required laboratory diagnostics software relying on our healthcare software development expertise. ScienceSoft gathered a full-fledged team for the medical device software project: a project manager, a business analyst, a regulatory expert, 2 software developers, a QA engineer, a UI designer.

Requirements analysis and software design

ScienceSoft’s team started by careful elicitation of the Customer’s technical and business requirements to design lab diagnostics software fully meeting end-user needs (laboratory technicians, supervisors, etc.).

During the design process, the team took into account human factors (use errors, critical task errors, etc.) and safety and usability of intended lab diagnostics software use to minimize potential usage risks (e.g., software misuse) and security threats. All these aspects were reflected in the technical design of software and the software development plan.

Laboratory diagnostics software development

ScienceSoft built, ensured integration capabilities, and carried out comprehensive testing of lab diagnostics software. Software worked as follows:

• A laboratory technician uploaded raw test files from laboratory equipment software to the Customer’s software.
• Laboratory diagnostics software run a quality check on the raw test data and identified whether the test complied with the set quality requirements.
• If the test didn’t meet the quality requirements, laboratory technicians could archive it and rerun the test.
• If the test met the quality requirements, the diagnostics solution proceeded to interpret the test results and checked them against the pre-set normal test results parameters.
• Then, the laboratory technicians sent the file with the interpreted test results to their LIMS (Laboratory Information Management System).
• The laboratory technicians could view the data on the previous screening test checks using a list view or a dashboard.
• The test results that were out of the pre-set range were highlighted to draw medical staff’s attention to the abnormal parameters.

Lab diagnostics software compliance

As laboratory diagnostics software was considered IVDR accessory software, it was planned and delivered in accordance with IVDR (In Vitro Diagnostic Regulation), Medical Device Regulation (MDR), IEC 62304, ISO 14971, ISO 13485, IEC 82304-1 standards.

To adhere to the MDR requirements, ScienceSoft prepared the CE marking submission documents concerning In Vitro Diagnostic software design, development, testing, risk management, and risk traceability.

Results

In 7 months, the Customer received fully functional CE-marked laboratory diagnostics software and was ready to offer it to their clients. As a result, the Customer improved client experience with their genetic screening kits and helped their clients ensure test accuracy and fast results interpretation.

Being pleased with the technical skills of ScienceSoft’s medical software development team and smooth project communication, the Customer continued the collaboration. They entrusted ScienceSoft with a year-long support project of developed software for laboratory diagnostics.

Technologies and Tools

Qt, Qt QML, C++, JavaScript, Git, CMake, NSIS, Doxygen, SQLite.