FDA
The new article elaborates further on the requirements to be fulfilled by the entities involved in the activity considered remanufacturing based on considerations described in the previous article.
FDA
The article highlights the key points related to the regulatory framework for remanufacturing medical devices, outlining the main considerations and critical aspects.
FDA
The article provides an overview of the regulatory approach to be applied concerning certain regulatory matters.
FDA
The new article further elaborates on the scope of documentation to be provided concerning cybersecurity devices intended to be marketed and used in the US.
FDA
The new article provides additional details regarding specific aspects associated with cyber devices, such as modifications to it.
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