Operating system compliant with IEC 62304 and FDA?
When selecting an operating system, do medical device manufacturers have to ensure that the operating system is IEC 62304-compliant? What does the FDA say? This article…
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.
SBOM: Software Bill of Materials
Laws and standards require medical device manufacturers to compile a Software Bill of Materials, the SBOM. However, standardized SBOM formats are not always sufficient to meet these requirements. In particular, medical device manufacturers who do not supply and use SBOMs for their software are no longer accepted in the market. Here are the reasons.
DetailsOff-the-Shelf Software (OTS) versus SOUP
Both the FDA and IEC 62304 recognize software developed by third parties. They refer to Off-the-Shelf Software (OTS) and Software Of Unknown Provenance (SOUP). What is the difference between OTS and SOUP? What do they have in common? What legal requirements do they have to meet? This article provides answers.
DetailsValidation of machine learning libraries
More and more manufacturers are using machine learning libraries, such as scikit-learn, Tensorflow, and Keras, in their devices as a way to accelerate their research and development projects. However, not all manufacturers are fully aware of the regulatory requirements that they have to demonstrate compliance with when using machine learning libraries or how best to…
DetailsIVD software manufacturers take note
This article describes the requirements of the in vitro diagnostic medical device regulation (IVDR) for software development and documentation. The requirements apply to software that is part of an IVD (embedded software) and to software that is an IVD itself (“standalone” software). This article also compares the software requirements of the MDR and the IVDR.
DetailsSoftware unit: specifying and testing according to IEC 62304
The term software unit is defined in IEC 62304. Many manufacturers experience difficulties when specifying and testing these software units. This article gives you tips on how to avoid them.
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