Regulatory Technology Services LLC is a limited liability company registered with the state of Minnesota.

Regulatory Technology Services LLC currently employs 3 reviewers and part time staff to complete reviews to meet customer requirements. The sole business purpose of Regulatory Technology Services LLC, is to perform third-party reviews of 510(k) submissions under the FDA Accredited Person Program. 

Devices that have been reviewed by Regulatory Technology Services 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 Regulatory Technology Services LLC.

Since 2003 Regulatory Technology Services has reviewed more than 900 submissions. Through this experience with Regulatory Techology Services and the medical device industry, Regulatory Technology Services' primary reviewers have reviewed hundreds of 510(k) submissions. 

Regulatory Technology Services LLC
1394 25th Street NW
Buffalo, MN 55313
Phone: 763.682.4139 Fax: 763.682.4420
E-mail Mark Job at: mark@markjob.com