EU
The article provides a general overview of the EU vigilance regulatory framework.
FDA
The new article highlights the aspects related to monitoring methods and associated matters.
HSA
The new article addresses the aspects related to the sources of data used in the context of clinical evaluation of medical devices.
HSA
The new article addresses the aspects related to the key concepts used in the context of clinical evaluation.
EDA
The new article addresses the aspects related to the minimum criteria an adverse reaction report should meet to comply with the respective requirements.
Gartner® Market Guide for Life Science Regulatory Information Management Solutions
Download NowGartner® Market Guide for Regulatory Intelligence Solutions
Download Now
