The student will become familiar with general information and definitions according to regulations, recommending documents and international standards in the field of regulatory requirements for the production of medical devices. Great emphasis will be placed on the ability to optimize the clinical evaluation process due to the possibilities of the technologies used for the production of MD prototypes. In the production of MD prototypes, new technologies are often used, especially 3D printing, which provides a cheap and fast tool for the realization of prototype solutions. It is possible to use these technologies with advantage, however, it is necessary to correctly set the processes that are connected with the technology itself and have an influence on the course of the aluminum test or clinical evaluation.