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), [...]

Let’s flip the European innovation model on its head Innovation is synonymous with progress. Embracing innovation means embracing the need to improve the sustainability and efficiency of healthcare systems by encouraging new business models, unlocking new market opportunities and improving health outcomes. Uptake of innovation in technology and services, however, could be quicker on the [...]