Welcome To Regulatory Insight

A Worldwide Industry Leader in Medical Device Regulatory Compliance

Submission, Training, Export & Import Services


About Us

For two decades, Regulatory Insight has provided comprehensive worldwide regulatory medical device consulting services to over 700 global clients in the medical device and IVD industries, ranging from small-scale start-up companies to established Fortune 500 corporations.

Just a sample of what Regulatory Insight can help your company obtain: 


  • FDA PMA Premarket Approval

  • FDA 510(k) Premarket Clearance

  • FDA and other Regulatory Body Accepted Clinical Studies

  • FDA and ISO 13485 Compliant Quality Systems

  • MDSAP Audit Program

  • FDA 483 Warning Letter

  • FDA Establishment Registration and Device Listing

  • U.S. Agent Representation for Medical Devices

  • Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID)

  • Medical Device Single Audit Program (MDSAP) Preparation

  • Health Canada Medical Device and Establishment License

  • European Commission CE mark for Medical Devices

  • Australian TGA Registration for Medical Devices

  • Employee Regulatory and Quality Systems Training for Medical Devices

  • Assistance with Medical Device Import and Export Issues

How We Can Help


Regulatory Insight has experience with a vast array of medical devices and IVDs. To see a some of the devices we have experience with click on the link below.


US Agent Regulatory Insight has registered many importers of medical devices with the FDA and can register your company with the FDA as an Initial Distributor as well. If your company is based outside the U.S. and your medical devices are being imported into the United States, your company must also be registered with the FDA as a manufacturer, foreign exporter or other type of establishment, as applicable.


Kevin Walls, MBA

Principal Regulatory and Quality System Consultant 

FDA medial device approval.  FDA approval for medical devices.  FDA medical device compliance

Kevin has over 30 years of medical device and IVD experience in worldwide regulatory affairs and quality assurance.


Kevin has worked both in the U.S. and abroad obtaining medical device regulatory approval, clearances, registrations and licensing, along with setting up new, and remediating existing quality systems.

Kevin has a B.S. in Electrical Engineering and an M.B.A. and received Regulatory Affairs Certification by the Regulatory Affairs Professional Society (RAPS). 


Kevin can be reached at +1-720-962-5412 or kevin@reginsight.com

Elvira Cawthon

Principal Clinical Consultant

Approval by the FDA for medical devices.  FDA medical device compliance and submission of medical devices t the FDA

Elvira has over 25 years of experience in clinical trial design, management and outcomes analysis, medical market research and clinical practice. 

Elvira has worked both in the U.S. and abroad with leading medical device research organizations and private companies. 

Elvira has both a B.S. and M.S. degree in the medical field.

Elvira can be reached at +1-615-447-5150 or elvira@reginsight.com

Worldwide Regulatory Medical Device Import/Export Services