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.
FDA
The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.
Australia
The article highlights the aspects related to the inclusion of new products in the Australian Register of Therapeutic Goods (ARTG), a country’s register of healthcare products allowed for marketing and use in the country.
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
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