Software Of Unknown Provenance. In some instances this may be legacy custom software but these days it probably means the integration of an open source program or library into your product. Both want the risks of device software addressed but each require slightly different deliverables to be compliant.
Software developed and maintained with respect to IEC 62304 requirements or with respect to medical devices regulations are not SOUP. SOUP can be used for medical device software. SOUP Software of Unknown Provenance Anomaly Documentation.
Solar Optical Universal Polarimeter experiment SOUP.
Imaging to a patient and at some point an operator will be involved even if only collecting the data. Aug 14 2020 1. SOUP can be used for medical device software. SOUP List Software of Unknown Provenance The 62304 requires you to document your SOUP which is short for Software of Unknown Provenance.