As omics-wide technologies progressively evolve, they are increasingly applied in diagnostics and to support clinical studies. This is associated with increased requirements for developing classification models using machine learning. To meet these requirements and to pave the way for omics-wide diagnostics in immune oncology and oncology, we recently (2020/2021) implemented software development processes according to the international standard IEC 62304 for medical devices. This process landscape combined with a certified quality management system (ISO9001:2015) enables us to develop under a controlled process algorithm for personalized medicine as well as software prototypes for in vitro diagnostics or lab developed tests.