Regulatory Intelligence for Medical Device Manufacturers

Medical devices manufacturers are nowadays due to the covid-19 pandemic facing enormous pressure to increase their production capacities and the rapid development of new products, which they then need to introduce to the market in the shortest possible time for a return on investment. Due to pandemics, the medical device market and the overall demand for specific products is very volatile, which is why it is crucial to know and be familiar with the often changing legislative requirements so that the whole process is as efficient as possible for all stakeholders involved. The thesis focuses on the European Union market and aims to develop a general methodology for placing a medical device on the market. The methodology should be easily applicable to all types of medical devices, and at the same time, its individual sections can be partially automated using an early warning system. For automation, elements of Regulatory Intelligence will be applied in the form of web alerts, consolidation of information sources into clear RSS feeds, and subsequent sharing of information to end-users.