DRAP
The new article describes in detail the approach to be followed when it comes to the assessment of adverse events.
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.
EDA
The new article highlights the aspects related to the vigilance system introduced to ensure the continued safety of medical devices allowed to be marketed and used in the country.
EDA
The document clarifies the aspects related to pharmacovigilance and its importance for ensuring continuous safety of medical devices allowed for marketing and use in the country.
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