Regulatory Technology Services
Regulatory Technology Services (RTS) is a limited liability company registered with the state of Minnesota.
RTS currently employs full-time and contract reviewers. The sole business purpose of RTS is to perform third- party reviews of 510(k) submissions of medical devices and in-vitro diagnostics (IVD) under the FDA Accredited Person Program.
Devices that have been reviewed by RTS include*:
Cardiovascular Catheters
Surgical Lasers
NIBP Monitors
ECG monitors
X-ray systems
Ultrasound systems
CT and MRIs
Picture Archiving Systems (PACS)
*This list is not inclusive of all types of products reviewed by RTS.
The Devices & IVDs that RTS is qualified to review are listed on FDA website.