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.

Regulatory Technology Services
1000 Westgate Drive, Suite 510k
Saint Paul, MN 55114