Clear SOUP and COTS Software for Medical Device Development
In many industries, manufacturers have reduced development times by using COTS (commercial-off-the-shelf) software and hardware. Pressures to bring new, feature-rich products to market quickly affect medical device manufacturers as much as anyone, but the industry may be reluctant to follow suit. This is due to concerns that COTS implies SOUP (software of uncertain provenance) may compromise device safety and pre-market approval by the FDA and other regulatory agencies. While we should exercise diligence and caution when considering COTS software, COTS software may be perfectly acceptable, given stringent selection criteria and validation of the completed systems and devices. If we make the distinction between opaque SOUP and clear SOUP, we will find that COTS software may be the optimal choice for many safety-related medical devices.
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