- 510(k)/PMA submission specialists
- Experts in consulting for overseas producers of regulated products
- 20 years experience in consulting for UV-emitting devices
Submissions
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.
Consulting
We have 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.
More
Contact us for a quote by clicking on the Information Request link or by phone / email. We will be happy to submit a written cost analysis of our services within 48 hours after having received your inquiry.
If you are a sunlamp or sun tanning equipment producer, please contact us to receive our Guidance Document, "Instructions to Sunlamp/Equipment Manufacturers under 21 CFR 1040.20" in PDF format via email. 
Our professional staff of technicians is ready to serve our clients' needs by traveling to their facilities with very little prior notice.