Medical Devices
In today’s rapidly evolving healthcare landscape, medical device manufacturers face the dual challenge of driving innovation while ensuring regulatory compliance.
FDA
The new article provides a detailed overview of certain specific regulatory aspects associated with x-ray devices intended to be marketed and used in the US.
FDA
The new article clarifies the requirements pertaining to the date of manufacture and also highlights the measurement-related matters.
MDCG
The document provides an overview of the EtO regulatory status and highlights the key points to be taken into consideration by the medical device manufacturers utilizing it in their processes.
FDA
The article highlights the key points related to the radiation control legal framework.
DRAP
The article provides a general overview of the pharmacovigilance system, highlighting the key points and aspects.
