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 300 submissions averaging approximately 30 days from receipt of the submission to receipt of the Substantial Equivalence letter from the FDA. This turnaround time is what our customers have grown to expect.
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.