BfArM
The new article describes the approach to be followed by the applicants when presenting sufficient evidence demonstrating the proper performance of their products when used for the intended purpose.
FDA
The new article describes in detail the aspects related to different types of MRI safety labelling to be used to indicate the safety status of the device intended to be marketed and used in the US.
EDA
The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto.
FDA
The article highlights the aspects related to various hazards associated with the use of medical devices magnetic resonance environment.
Swissmedic
The article provides an overview of the trend report template issued by the Swiss regulating authority.
