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RTS is an FDA-accredited Third-Party Review Organization (3PRO) that is authorized to review 510(k) submissions for selected low-to-moderate risk medical devices. Initially accredited by the FDA as a third-party reviewer in 2003, we have reviewed more 510(k) submissions than any other 3PRO and have consistently conducted more reviews annually than any other 3PRO in the industry. Under the FDA Program, RTS is subject to an FDA audit every three years. The Program allows a manufacturer to submit a 510(k) directly to a 3PRO such as RTS instead of to the FDA.