
MDCG Revised Guidance on MDR Application for Legacy Devices: Details
The new article provides additional clarifications regarding specific aspects of the regulatory approach to be followed.
The new article provides additional clarifications regarding specific aspects of the regulatory approach to be followed.
The article provides a general overview of the applicable regulatory requirements and highlights the key points associated thereto.
In today’s rapidly evolving healthcare landscape, medical device manufacturers face the dual challenge of driving innovation while ensuring regulatory compliance.
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.
The new article clarifies the requirements pertaining to the date of manufacture and also highlights the measurement-related matters.