EU
The new article provides additional clarifications concerning the content of submissions associated with clinical investigations and modifications to it.
EU
The article provides an overview of the regulatory approach to be applied with respect to clinical investigations involving medical devices in the context of exemptions.
EU
The new article highlights the aspects related to the existing regulatory pathway, the approach to be applied for different types and classes of medical devices, and the way the intended purpose of the device in question should be considered.
HSA
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
FDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
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