The new article highlights the key points related to study procedures in pediatric clinical investigations, and also provides a summary of the key points...
The article provides an overview of the regulatory policy related to the Abbreviated 510(k) Program and highlights the key points associated thereto.
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The article provides an overview of the existing regulatory requirements related to the abridged processing of applications for medical devices.
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The new article highlights the aspects related to the changes to registered medical devices implemented in response to adverse events, the context of field...
The new article describes in detail the aspects related to a risk-based approach and the way it should be applied concerning computer software assurance...