Software as a component of in vitro diagnostics (IVD) and medical devices has to meet the highest quality requirements to be safe and efficient. Thus the EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Medical Device Regulation (IVDR) require amongst others state-of-the-art software development and risk management processes. The state of the art is provided in the international standards IEC 62304 and ISO 14971.

The Fraunhofer IZI Bioinformatics Unit implemented the required software development processes. We used these processes to create a software prototype to calculate a classifier for the prediction of the aggressiveness of prostate carcinomas based on RNA sequencing [1]. Based on the creation of this prototype the Johner Institut GmbH performed an audit to verify that the implemented processes are conform to the standard. We successfully passed the audit. The auditors express "great confidence of a standard-compliant software development".

The establishment of software development for medical devices, in particular for in vitro diagnostics, extends the service portfolio of the RIBOLUTION Biomarker Center. Under the umbrella of the Biomarker Center, developments for molecular diagnostics can thus be fully implemented. Controlled processes for software development combined with a certified quality management system (ISO9001:2015) and years of experience in Next Generation Sequencing (NGS) technologies, data science and machine learning enable the Biomarker Center to develop software prototypes for in vitro diagnostics or lab-developed tests. This enables research results to be used even more quickly for applications in personalized medicine for the benefit of patients. This strengthens translational research at Fraunhofer IZI in the field of biomarkers and diagnostics.

Further information about the RIBOLUTION Biomarker Center

This project funding was provided by EFRE and administered under the account number 100382213 by Sächsische Aufbaubank.

[1] https://pubmed.ncbi.nlm.nih.gov/32631745/