EDA
The new article addresses the aspects related to the minimum criteria an adverse reaction report should meet to comply with the respective requirements.
FDA
The article addresses the aspects related to possible image artifacts and the way they should be treated and also describes the approach to be applied when reporting results.
FDA
The article provides an overview of the regulatory requirements related to safety in the magnetic resonance environment and highlights the key points to be taken into consideration by medical device manufacturers and other parties involved.
FDA
The article highlights the aspects related to certain specific hazards associated with the use of medical devices in the magnetic resonance environment – namely, displacement force and torque.
EDA
The new article highlights the aspects related to the vigilance system introduced to ensure the continued safety of medical devices allowed to be marketed and used in the country.
