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.
BfArM
The new article addresses the matters related to interoperability for medical software products.
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.
FDA
The article describes in detail the aspects related to the use applicability of the electronic submission framework in case of innovative products to be placed on the market.
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