Abstract:

The medical device industry in Europe is one of the sectors actively regulated by directives. Medical device manufacturers face the challenge of implementing the statutory regulations. 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, which different validation approaches exist, and which tasks and activities are to be carried out within the CSV. One focus of this research is the critical consideration of the problems associated with CSV for small and medium-sized enterprises (SMEs). As a result of this research it can be stated that the identified literature sources are very homogeneous, and the validation approaches do not show any significant differences.