AEGIS REGULATORY P.A.

Our firm specializes in 510(k) / PMA submissions, and offers manufacturers the ability to obtain import and market approval in shorter time periods than is common. We also have over 20 years of experience in composing Initial, Model Change, and Annual Reports for UV-emitting devices, and provide both in-house and mobile NIST-calibrated spectral analyses. Our professional staff of technicians is ready to serve our clients' needs by traveling to their facilities with very little prior notice.

Also known as: FDA Listing Consultants

Primary location: Knoxville United States