ARQonNov 20, 20181 minUS FDA releases Modifications to the List of Recognized StandardsThe US FDA announced a publication containing modifications made to the list of standards FDA recognizes for use in premarket review (FDA...
ARQonNov 19, 20181 minApple obtains last minute De Novo application approval: Just in time for the Apple Watch 4 revealApple worked closely with the Biologics Consulting Group to attain approval for the De Novo request for their new ECG app on the Apple...
ARQonNov 14, 20184 minChina Releases Document on Local Representatives' obligations and bolsters Adverse Event ReportiDraft on Local Representatives' Obligations In order to ensure the safety and effectiveness of imported medical devices, NMPA has...
ARQonNov 13, 20182 minUS FDA introduces cyber-security considerations for Tier 1 & 2 Devices and clarifies CBOM importFor this cyber-security guidance only, FDA introduces the tiers of higher and standard cyber-security risk to aid medical device...