USA – FDA proposes framework for human factors information in device submissions
The US Food and Drug Administration (FDA) last week issued draft guidance outlining a risk-based framework about what human factors information should be included...
USA – FDA aims to clarify device malfunction summary reporting requirements
In a new draft guidance issued on Thursday, the US Food and Drug Administration (FDA) aims to clarify how manufacturers can voluntarily submit malfunction...
USA – Theranos : onze ans de prison contre Elizabeth Holmes, patronne déchue, condamnée...
L’ancienne star de la Silicon Valley Elizabeth Holmes, reconnue coupable de fraude en janvier, a été fixée sur sa peine, vendredi 18 novembre, près de...
