EU
The new article provides an in-depth overview of the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
EU
The article highlights the key points related to the regulatory framework for reporting requirements in the context of certain studies medical devices are subject to.
FDA
The new article describes in detail the approach to be applied with respect to data collection and reporting in the context of animal studies.
FDA
The new article provides additional recommendations to be taken into consideration when preparing the submission, in particular with respect to study design and execution.
FDA
The article provides an overview of the existing legal framework and also describes the key concepts related to the matter.
