
BfArM Guidance on Statistical Requirements for Clinical Trial Authorization
The article provides an overview of the authorization process for clinical trials involving medical devices to be conducted in Germany.
The article provides an overview of the authorization process for clinical trials involving medical devices to be conducted in Germany.
The new article describes in detail certain specific aspects associated with registrations necessary to make submissions associated with healthcare products.
The article provides a brief overview of the regulatory approach to be applied with respect to certain tests intended to be used in the context of an emergency.
The new article elaborates on the specifics of the regulatory approach medical device software products are subject to.
The article provides an overview of a checklist outlining the main principles to be considered with respect to medical devices intended to be marketed and used in Australia.