MDCG Revised Guidance on MDR Application for Legacy Devices
The article highlights the key points related to the regulatory status of legacy devices.
The article highlights the key points related to the regulatory status of legacy devices.
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.
The new article describes in detail certain specific aspects related to the regulatory status of endosseous dental implants and performance criteria they should meet in order to be allowed for marketing and use in the US.
In today’s rapidly evolving healthcare landscape, medical device manufacturers face the dual challenge of driving innovation while ensuring regulatory compliance.
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