Notably, many of the medical device faults stem from product upgrades. An analysis of 3140 medical device recalls conducted between 1992 and 1998 by US FDA, reveals that 242 of them (7.7% of the total ...

Until recently, safety regulations for medical device software, at least formally, were not exceptionally rigorous across the board. In addition, software was not formally classified as a medical ...

Does anyone have experience of writing software for class B/C medical devices (not quite certain which right now, but it's a in-vitro diagnostic device ) and in particular the use and verification of ...