FDA
The new article highlights the aspects related to the device description to be included in premarket notification submissions under the respective legal framework.
FDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
ANMAT
The article provides an overview of the new regulation and highlights the key points associated thereto.
FDA
The article addresses the aspects related to the existing legal framework associated with AST system devices and highlights the key points to be considered. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
Uncategorized
This blog highlights the importance of regulatory compliance for medical device manufacturers, roadblocks and key steps to navigate through them. Table Of Contents: Medical devices play a crucial role in the healthcare ecosystem, aiding in the diagnosis, treatment,...
