Regulatory Technology Services LLC was established in 2003 and has been accredited by the FDA to perform third-party reviews of 510(k) submissions.
Since July 2003 we have reviewed more than 400 submissions averaging 7 to 10 days from the receipt of the submission to the completion of our intial review.
We have added staff to expand our capability to review more devices and so we may continue to provide the service which sets Regulatory Technology Services apart.