What is Software of an Unknown Provenance known as SOUP?

October 1, 2020

International standard IEC 62304 defines life cycle requirements for the development of medical software inside medical devices. This regulation is harmonized by the European Union and the United States and thereby serves as a standard by which to respect the regulations of both markets.

A SOUP is 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 a software item previously developed for which adequate records of the development process are not available.” (Source: IEC 62304). The FDA defines SOUP as some or all of the software contained in a software device may have been obtained by the submitter from a third party.” (Source: Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on May 11, 2005)

In other words, SOUP is a software of unknown provenance. It is an already developed software that was not initially designed for a medical application. For example, python interpreter falls within the scope of SOUP.

SOUP can be used for medical device software. However, a medical device software system cannot be claimed to be SOUP “(Source: IEC 62304)

A SOUP may have an impact on the medical device software without direct control from a developer. By using a SOUP to support software as a medical device, the regulations require that the following documents must be available:

  • A risk analysis of the SOUP and a justification of its use
  • Functional/performance requirements for every SOUP
  • Software architecture and hardware requirements for operating SOUP

As a SOUP upgrade or modification can modify the software behaviour, a plan management and maintenance of SOUP, as well as a product labelling, must be provided.

Difference between SOUP and OTS:

  • Off-the-shelf software (OTS Software) is a generally available software component adopted by a medical device manufacturer. The manufacturer cannot claim the complete control of the software life cycle.
  • Commercial off-the-shelf software (COTS Software) is an OTS software coming from a commercial supplier.

SOUP encompasses software that is not generally available (i.e. legacy components previously developed by the manufacturer without software life cycle processes to follow and document). This kind of software is not included in OTS.

On the contrary, OTS includes software that is generally available and a component of a medical device (i.e. library or operating system embedded in a medical device).


Author: Alix Auter, Life Science Consultant KVALITO 

If you would like to benefit from KVALITO’s specialized services, please get in contact: client.partner@kvalito.mardeasa.es.

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