Analysis of reasons causing development of malfunctioning software in medical equipment

In the world today, the vast majority of medical electronic equipment contains software. Very often even the computer software is classified as an independent medical part. Because of the ease of making changes to the element of a large functional complexity, there is a high risk of introducing errors in the modified software. For example, just entering the wrong one filter parameter can make the biomedical signal processing circuit work incorrectly. As noted in [5], "the lessons learned from … disasters can do more to advance engineering knowledge than all the successful machines and structures in the world". This statement is also true in the software domain. The main goal of this paper is - basing on a database of medical devices with software defects - to draw conclusions and guidance for the design and maintenance of software for new medical equipment.