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There is no arguing that digital transformation has helped revolutionise many industries, including healthcare. In my role as a data scientist, I have seen our field’s solutions and strategies change as technology advanced and patients’ expectations evolved. Now that I work as a data and Artificial Intelligence (AI) partnerships lead, I strive for a multi-disciplinary […]

January 2012 was a fruitful month for EU guidance on medical devices and produced among other MEDDEVs the MEDDEV 2.1/6 Qualification and Classification of stand alone software. This MEDDEV contains the latest thinking on how stand alone software, i.e. software that does not necessarily run on a medical device (but may have medical device functionality), qualifies as medical device under the three medical devices directives. If you are interested in a lot more background about the MEDDEV than I can provide in this blogpost (and especially nice flowcharts, which make life more simple for everyone), you can find it here.