Abstract:

The medical device industry in Europe is one of the sectors actively regulated by directives. Amendments of legal regulations in the medical device industry forces manufacturers to permanently review and adapt their business processes. In the context of current trends regarding the digitalization of enterprises, among other things, a focus is on the computer system validation (CSV). The present research shows why the CSV in the medical device industry is necessary and which problems are associated with the CSV especially for small and medium-sized enterprises (SMEs). Main outcome of this paper is a research framework that helps to examine the relationship between firm-specific information technology (IT) and risk management capabilities, CSV and firm performance of SMEs in the medical device industry.