Alexander Wassel

Software as Medical Device

By Alexander Wassel November 17, 2023 Leave a comment

Software as Medical Device (SaMD) refers to (independent) standalone software that is a medical device but not part of one. It should not be confused with Medical Device Software as defined by the EU. As a manufacturer, when do you have to qualify Software as Medical Device, and when as Medical Device Software? Find out…

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Off-the-Shelf Software (OTS) versus SOUP

By Alexander Wassel October 30, 2023 Leave a comment

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. 1. SOUP and OTS: definition…

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