RTS

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... We are a highly qualified team of reviewers who possess the scientific, technical and regulatory expertise to review the broad range of Class I and Class II medical devices that are eligible for 3PRO review. That range of expertise has resulted in RTS being the only third-party review organization to be accredited by the FDA to review medical devices in all twenty medical specialties/review panels on the Agency's list of devices eligible under the FDA's 3P510(k) Review Program... We are committed to continuing to work with the FDA to promote the Third-Party Review Program so medical device manufacturers will be able to bring their products to market faster and so the FDA can focus more of its resources on the evaluation of pioneering technologies that..