BioSistemika published an article by Head of Engineering Anže Videnič examining the challenges and gaps in laboratory software for regulated markets.

BioSistemika specializes in custom software development, digitalization consulting, and development of laboratory software products. Over the past 10 years, we have worked with many laboratory instrument manufacturers and delivered software products that were tailored to our customer needs. We have completed several in vitro diagnostic (IVD) projects and non-IVD software projects for our customers for which we developed entire software product suites, starting from requirements, design specification, coding, and testing. For IVD, we are working in accordance with ISO 13485 and IEC 62304. We have vast experience in software-hardware integrations and are supporting standardization efforts that enable interoperability. BioSistemika also has immense experience with resolving compatibility with laboratory equipment, other software systems, connections between coding languages, big data storage, and analysis. We aim to empower scientists with professional software that has an excellent user experience. Years of experience in customizing software solutions gained us trusted partners. We cooperate with leading Life Science companies such as Gilson, Agilent, Alifax, ADInstruments, 4titude, and many others. BioSistemika has also consulted the most prominent companies about setting up a digitalization strategy. We help to implement it and build all the missing links by integrating existing software solutions or building new ones. We have successfully collaborated in multiple grant-funded R&D projects as well as lead international consortia. We have an experienced project management team and back office at our disposal, capable of coordinating and managing complex R&D activities, administration as well as the subsequent commercialization stages.