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.
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.
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