IVD software integrated with qPCR instrument

Windows Desktop Application developed in C#, .NET Framework, WPF, SQLite

Alifax S.r.l. specializes in development, production and distribution of clinical diagnostic instrumentation for laboratory automation. They have developed a Molecular Mouse instrument, a portable thermal cycler, with a ready to use cartridges for detection of microorganisms in clinical samples.

Diagnostic tests performed on a Molecular Mouse system enable fast detection and analysis of microorganisms with a quantitative PCR method following a highly automated workflow that requires minimal user input. The software is an IVD registered product.

BioSistemika developed a Windows desktop application that supports control of up to 6 Molecular Mouse instruments, enables automatic analysis of acquired data, generation of reports, and integration with laboratory information systems.

The IVD software was developed according to IEC 62304 standards to meet IVD 98/79/CE Directive.

Software screens

A Windows desktop application was developed in C#/.NET and can control up to 6 Molecular Mouse instruments via USB connection. The application includes graphical user interface that allows users to analyze, interpret and visualize the results. Data of the application is stored within an encrypted SQLite database.

The software also manages data connections to a LIMS system to import sample data and export results.

Developing an IVD software is a rigorous and complex process that includes strict quality management of the requirements, specifications, development, and testing processes, as well as ensuring specific qualities of the final software are met. We have prepared all the necessary software documentation, traceability matrix, list of SOUPs, test plans and reports, as well as implemented unit tests for the critical units of the software.