By Marion Lepmets, CEO of SoftComply* & Tom Stamp, CEO of Blue Curve** Following our article from last week on “Is My Software a Medical Device” to those of you who are now convinced that your software is indeed a duck (see the original article), then you are probably wondering “How do I get it […]
Is Europe More Innovative Than the US?
Europe has a more distributed approval system which has resulted in medical devices being approved and made available in Europe three to four years before these devices are approved in the US1. Even if Europe provides a faster route to market for medical device products, it has not affected their safety, i.e. there is […]