BfArM
The article highlights the aspects related to the life cycle of the digital health applications included in the respective directory.
FDA
The article provides a general overview of the guidance document issued by the US authority and highlights the key points related to the existing legal framework.
SAHPRA
The article highlights the key points related to the licensing regime for medical device establishments.
FDA
The new article highlights the aspects related to the general regulatory framework for computational modelling and simulations used in the healthcare sphere in the context of medical device development.
FDA
The new article highlights the aspects related to the design of animal studies involving medical devices to be considered by the responsible parties in order to ensure the accuracy and reliability of the results.
