Dec 28, 2023
FDA
The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.
Read More
Dec 20, 2023
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.
Read More
Dec 20, 2023
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.
Read More
Dec 20, 2023
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.
Read More
Dec 20, 2023
FDA
The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.
Read More
Dec 19, 2023
FDA
The new article highlights the aspects related to the way animal studies should be planned and conducted, including the facility selection, as well as keeping animals during the study
Read More