The course is aimed at those who work with medical devices and software and need an overview of the requirements introduced for software with regard to the Medical Device Regulation (MDR).
The medical device industry is subject to the Medical Device Regulation (MDR) and in order to sell medical devices, the manufacturer must CE mark according to these requirements.
This course gives you an overview of the requirements introduced for software with regard to MDR. We look at the definition of Software as a Medical Device (SaMD) and the application of a medical device software - throughout the entire life cycle, focusing on ease of use, a risk-based approach, software development, as well as what software documentation should be included in the technical file.
At the end of the course, you should have an overall view of the software development process according to the MDR framework. You will be able to use your new knowledge in current and future software development projects. You will know what is required to develop a software process.