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Preparing for FDA Premarket Approvals
Great emphasis is given to 510(k) submissions when talking about marketing medical devices and in vitro diagnostic products in the US, and most Regulatory Affairs teams are well-prepared to plan and execute them. However, that is not the case when it comes to premarket approvals (PMA), the stringent process required for most class-III devices and new high-risk devices for which there is no substantially equivalent device on the US market. In this Keynote, we will discuss the applicability of the De Novo and PMA processes, situations in which Q-submissions are indicated, clinical data requirements for a PMA, including the application for investigational device exemption (IDE), and the necessary adaptations of the quality management system.
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