The new article highlights aspects related to clinical outcomes to be used in the context of studies involving devices intended to treat opioid use disorder. In particular, the article describes in detail the change in drug use as one of the possible clinical outcomes...
The new article highlights the aspects related to the documentation to be provided by the medical device manufacturer with respect to the product subject to review in terms of its description, as well as testing, verification, validation activities, and conformity to...
The article provides a general overview of the regulatory requirements for the registration of new medical devices relying on CE certificates that are either expired or about to expire. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA),...
The new article addresses aspects related to the submission of the request for reconsideration and its subsequent review by the Minister. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
The new article highlights the aspects related to the testing to be conducted in order to assess the relevant mechanical performance of bone plates and screws. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...