Software for medical devices

A regulatory approach to medical device software (SaMD & MDSW)


The course is aimed at those who work with medical devices and software, who are professionals in e.g. QA, RA or R&D in the medical device sector and who need a clear picture of the regulatory landscape. Also suitable for those who have plans to develop medical device software (MDSW) and software as a medical device (SaMD).


During this training you will get a comprehensive overview of best practices and requirements in medical device software development. After the course, you will have a good understanding of the regulatory requirements for software development, based on the Medical Device Regulation (MDR) and IEC 62304. You will also get an overview of other relevant guidelines and regulations that represent current best practice. This area is evolving at a fast pace and you need a methodology to address the changing regulatory landscape. The course covers topics such as development according to IEC 62304 in depth, current guidelines and regulations in Artificial Intelligence (AI), Cybersecurity and the difference between Medical Device Software (MDSW) and Software as a Medical Device (SaMD) and more.