FDA The article provides an overview of the regulatory framework related to the quality system information and highlights the most important aspects associated thereto. Table of Contents The Food and Drug Administration (FDA or the...
Asia The new article provides additional details regarding the new regulation on clinical trials for medical devices published recently in Turkey. In particular, the article addresses the matters related to the reports associated with clinical trials and also outlines the...
FDA The new article highlights the aspects related to the requests for performance data in the context of 510(k) submissions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
Asia The new article describes in detail different types of data related to clinical evaluation. In particular, the present article addresses the matters related to the data generated through clinical experience, and the data from clinical investigations. ...
FDA The new article highlights certain specific aspects to be considered, including design controls and following steps in clinical evaluation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
Ethiopia The new article describes in detail specific aspects related to the products placed on the market by virtual manufacturers and highlights the main points related to the responsibilities of all the parties involved in supplying medical devices in Ethiopia. ...
