Wessel Kooyman

Wessel Kooyman

The pros and cons of current regulations on using external software components in medical device software (SOUP or OTS)

The regulations around external software components are mostly risk-averse and safety oriented. This negates the benefit of updating components frequently. In this article, we look into this contradiction. Currently, when developing software for medical devices, there are two sets of rules that deal with external software components: IEC 62304 and the FDA guidance from 2019 […]