FDA
The new article highlights the aspects related to the device description to be included in premarket notification submissions under the respective legal framework.
EU
The article provides an overview of the provisions of a guidance document and highlights the key points to be taken into consideration by medical device manufacturers (software developers).
BfArM
The article addresses the aspects related to data protection in the context of digital health applications.
FDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
EDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
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