This course gives an idea of the regulatory requirements and where they come from.
The quality assurance requirements for medical software are becoming increasingly stringent. This creates additional obligations for manufacturers, the motivation for which is not necessarily transparent to all developers and testers involved. This course gives an idea of the regulatory requirements and where they come from.
In addition, basic methods of software testing in general and model-centered testing in particular are taught. The third day is dedicated to test management and further topics (usability, validation, 21 CFR Part 11).
