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.
HSA
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
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