CE-Marked Laboratory Diagnostics Software Delivered in 7 Months
Challenge
A European manufacturer of genetic screening kits for diagnostic laboratories needed accompanying software to go with its kits, software that would automate the processing of genetic screening tests and validate their quality. Because the product would be used in clinical diagnostics, it had to meet strict regulatory requirements including IVDR and ISO 13485, and carry a CE mark. To build it, the manufacturer needed an ISO 13485-certified medical software development partner capable of delivering compliant, safety-critical software.
A European manufacturer of genetic screening kits for diagnostic laboratories needed accompanying software to go with its kits, software that would automate the processing of genetic screening tests and validate their quality. Because the product would be used in clinical diagnostics, it had to meet strict regulatory requirements including IVDR and ISO 13485, and carry a CE mark. To build it, the manufacturer needed an ISO 13485-certified medical software development partner capable of delivering compliant, safety-critical software.
Solution
We designed, built, and CE-marked laboratory diagnostics software for the client's genetic screening kits, delivering it to IVDR and ISO 13485 standards within seven months. The application automates quality checks on genetic screening tests and the interpretation of the resulting test data, then feeds validated results into the laboratory's LIMS. It was built with a Qt and C/C++ core for the desktop application and a JavaScript, HTML, and CSS front end, engineered throughout to satisfy the regulatory and quality-management requirements of medical diagnostics.
We designed, built, and CE-marked laboratory diagnostics software for the client's genetic screening kits, delivering it to IVDR and ISO 13485 standards within seven months. The application automates quality checks on genetic screening tests and the interpretation of the resulting test data, then feeds validated results into the laboratory's LIMS. It was built with a Qt and C/C++ core for the desktop application and a JavaScript, HTML, and CSS front end, engineered throughout to satisfy the regulatory and quality-management requirements of medical diagnostics.
Results
The client received compliant, CE-marked diagnostics software delivered in just seven months, meeting IVDR and ISO 13485 requirements. Laboratories can now automate quality checks and interpretation of genetic screening test data, with validated results flowing directly into their LIMS. The manufacturer gained regulatory-ready companion software for its screening kits, backed by an ISO 13485-certified development process.
The client received compliant, CE-marked diagnostics software delivered in just seven months, meeting IVDR and ISO 13485 requirements. Laboratories can now automate quality checks and interpretation of genetic screening test data, with validated results flowing directly into their LIMS. The manufacturer gained regulatory-ready companion software for its screening kits, backed by an ISO 13485-certified development process.