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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. A 510(k) submitted by a manufacturer to a 3PRO is designated a 3P510k. RTS was initially accredited by the FDA as a third-party reviewer in 2003. Since then, we have reviewed more 510(k) submissions than any other 3P Review Organization and have consistently conducted more reviews annually than any other 3PRO in the industry.