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 describes in detail the aspects related to a risk-based approach and the way it should be applied concerning computer software assurance...
The new article describes in detail the process of determining whether computer software used in the context of medical device manufacturing processes should be...
The new article describes in detail the aspects related to smart regulation and global harmonization for all the procedures and processes related to placing...
The present article provides additional details regarding specific aspects related to the policy for monkeypox tests, including the ones related to validation, serology tests,...