WESTON, Mar. 5, 2020 — NIKAO is proud to announce that we are expanding upon our industry leading services to provide assistance to foreign medical device companies attempting to market their products in the USA.
Our strategic planning includes developing a strategy and partnership with foreign medical device class I and II manufactures who are not able to market their products due to constraints and lack of knowledge about 510{k} processes. Our specialty is preparing, submitting and shepherding 510(k) Premarket Notifications through the U.S. Food & Drug Administration (FDA).
We cater to foreign small businesses that manufacture medical devices for the American market. Whether you have a brand new product that you are looking to commercialize or need regulatory assistance with a currently-marketed product, we can help with all aspects of FDA regulatory submissions and strategy.
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