The how and the what of external software components (SOUP or OTS software) in medical devices
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 (‘Off-The-Shelf Software Use in Medical Devices’). IEC 62304 defines SOUP as follows: So it’s really part of the software – a package, a dependency, a module linked in.The […]
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 […]