Saudi Arabia
The article outlines the basics of the regulatory framework for innovative medical devices.
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.
Canada
The new article outlines the key considerations based on the class of the medical devices in question under the applicable risk-based classification system.
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