Great Britain
The new article provides additional clarifications regarding the upcoming changes to the UK regulatory framework.
IMDRF
The article provides a general overview of the key terms and concepts used in adverse event reporting related to medical devices.
IMDRF
The new article describes the key terms and concepts used in adverse event reporting for medical devices.
HSA
The article provides a general overview of the approach to be followed when preparing a submission associated with a medical device intended to be placed on the market in Singapore.
EU
The article provides a general overview of a vigilance system applicable to CE-marked medical devices intended to be marketed and used in the EU and also highlights certain specific aspects associated thereto.
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