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A comment on Why Are Ultrasound Machines So Expensive?. Parent comment

Re:Why Are Ultrasound Machines So Expensive? by jes on Thursday February 25, 2016 @12:39AM (#11172597)
That's an excellent observation. IEC 62304 speaks to these issues, although not in the context of open source per se.

It also depends on the class of your device (A, B or C in 62304 parlance) how much rigor you must put into your software process.

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