Classification of medical devices and their approval in the United States.
Amongst the team of experts at confinis, we have former FDA officers, with substantial and first-hand knowledge regarding the regulatory approvals of medical devices incl. in-vitro diagnostics in the US. In the US, most medical devices are subject to authorization while the approval method depends on the classification of the medical device.
We will tell you what you need to consider when seeking US approval and will support you in the product documentation. Our expertise will help you achieve regulatory approval in the United States without any detours.