Access to market United StatesThe American market for medical devices represents about 40% of the worldwide market for medical devices and, therefore, it is one of the most desirable markets for any manufacturer that intends to turn to the international market for the sale of its products, requiring just one registration.
In order to legally distribute and sell Class I, II or III, medical devices in the USA, manufacturers must identify the correct class of the product and make the notification or registration of the product, and of the plant at FDA, following the applicable procedures foreseen for the type of product.

FDA submissions

Maytal can support MD and IVD manufacturer for the editing of all the different FDA submissions:
And also perform:
Furthermore, Maytal is able to supply all regulatory consulting necessary to prepare the FDA submissions, like: