Does it make sense to use open source software components for the development of medical devices?

How about the handling of version control as well as responsibility and liability?

2 thoughts on “Does it make sense to use open source software components for the development of medical devices?

  1. Dear Sebastian Hallensleben,
    open source software is generally spoken not “better” or “worse” than commercial off-the-shelf-software (COTS). It depends on the chosen software-item you want to use.
    Given that the software of interest is not developed in accordance with IEC 62304: both, open source and commercial software, have to be considered as SOUP (software of unknown provenance – see IEC 62304), so you have (just to list some few requirements) to clearly specify the use of the SOUP-item, document the used version, make a risk estimation and determine if the item is suitable, evaluate published anomaly lists, etc. pp.
    Based on the above outlined requirements, you / your company must decide if it makes “sense” to use open source software (or closed source software either!).
    Kind regards, Hans

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