Certification for Medical Machine Learning

This project aims to identify regulatory requirements for the use and certification of machine learning algorithms for medical devices.

As the research in the field of AI technology is rapidly moving forward legal codes and technological states of the art are being interpreted differently or reworked entirely. Therefore, it has become increasingly difficult to ensure the compliance with all requirements.

The goal of the project is to compile a checklist in which the steps necessary for the development of a compliant product are listed with reference to the applying legislative act and technological standards as well as examples on how to implement them.