EU
The article highlights the key points associated with the regulatory status of certain products placed on the EU market and also describes in detail the approach to be applied with respect to qualification.
EU
The article provides a general overview of the approach to be followed when creating a clinical investigation plan for medical devices.
EU
The new article outlines the scope of general information to be covered by a clinical investigation plan a party responsible for the inquiry should prepare.
EU
The new article describes the way study benefits and objectives should be reflected in a clinical investigation plan.
EU
The new article provides additional clarifications regarding study design and data management aspects.
EU
The new article highlights specific aspects of a clinical investigation plan, such as the approach to be followed concerning the deviations or informed consent and how it should be obtained before commencing a study.
