Proregulations is about to participate in DCAT Week 2024, scheduled for March 18-21, 2024 (local time) in New York City. During DCAT Week 2024, staff at Proregulations will be in Converted Room #1415, Lotte NY Palace Hotel, 455 Madison Ave, New York, NY 10022. “Welcome to Lotte ...Learn More

Proregulations is a newly emerging regulatory consulting firm that specializes in assisting medical device manufacturers and companies in navigating the complex process of registering their products with the U.S. Food and Drug Administration (FDA). With its comprehensive range of ...Learn More

People who want to market their either Class I or Class II device products in the U.S, and the device is not exempt from 510(k), must file a Premarket Notification with the FDA, it is also known as FDA 510(k) submission. The 510(k) is a complex application to the FDA, because the ...Learn More