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.
FDA
The new article describes in detail the aspects of the different types of interactions with the authority within the Q-Submission concept, emphasizing their specific features and use cases
