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.
Australia
The article highlights the critical points related to the regulatory status of certain software products.
Australia
The new article provides an in-depth overview of the problems identified and solutions proposed by the authority, together with the questions to be answered by the key stakeholders.
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