EDA
The article highlights the key points related to the regulatory framework for recalls introduced in Egypt.
Swissmedic
The new article elaborates on the specifics of the regulatory approach medical device software products are subject to.
Bahrain
The article describes in detail the transitional arrangements associated with the recent regulatory changes in the European Union.
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.
EU
The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and explains the status of a legal representative.
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