Charles Plessy
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Bio-IT World published an article entitled "Open Source Pitfalls At The Biotechnology-High Technology Crossover" by Paul Liu (May 14, 2018) bio-itworld.com/2018/05/14/ope

In very brief, it reminds to people new to the field that open source softwares have licenses that vary in what they permit, and that one needs to be careful when combining software with different licenses. Key recommendations: monitoring, documentation, anticipation.

The article also states: "Use of a software product incorporating such open source license requirements in a medical device may increase the risk that the medical device is disapproved by regulatory bodies due to being tamper-prone or otherwise unsafe."

Is that or did that happen at least once in the past ?

@charles_plessy Open source FUD happens all the time. The specific incident of open source being a risk I'm pretty sure has yet to occur.

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