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.
FDA
The article provides a general overview of the revised guidance document and highlights the key points related to the existing legal framework.
FDA
The new article pays attention to the general questions associated with Q-Submissions that medical device manufacturers may use to request additional feedback from the authority before submitting an actual application for marketing approval.
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