“Swedish Document” reloaded – a new boost for medical devices standalone software regulation

Sweden is a lovely and industrious country that takes engineering very seriously; the small Scandinavian country that we know from its boxy but good cars also builds its own fighter jets (pretty good ones actually) and is determined to put its mark on the regulation of standalone software under EU medical devices law. The Swedish competent authority Läkemedelsverket has now issued a new version of the famous Swedish Document with the obvious agenda to influence guidance on standalone software under EU med [...] « Read the rest of this article on medicaldeviceslegal »