SOUP is an acronym for “Software of Unknown Provenance“. The IEC 62304 defines a SOUP as as a software item:

“that is already developed and generally available and that has not been developed for the purpose of being incorporated into the MEDICAL DEVICE (also known as “off- the-shelf software”) or SOFTWARE ITEM previously developed for which adequate records of the development PROCESSES are not available”

Please mind, that the term SOUP is not quite equivalent to the term OTS of the FDA.

Further information

Pay particular attention to this article on the similarities and differences between SOUP and OTS. It also presents the regulatory requirements for SOUP and OTS software and provides tips on selecting and using them.

Do you need support in evaluating COTS, OTSS, or SOUP to comply safely with the requirements of European and US regulations? Then don’t hesitate to get in touch with us. We will answer, even free of charge, in our micro-consulting service.