New EU IVDR Smart Builder now available

The newest RAMS Smart Builder walks you through the IVDR Technical Documentation File so you can save time and minimize errors that delay regulatory approval.

New EU IVDR Smart Builder now available

The newest RAMS Smart Builder walks you through the IVDR Technical Documentation File so you can save time and minimize errors that delay regulatory approval.

Experience you can trust

Developed by experts at Emergo by UL, RAMS offers a growing portfolio of EU MDD, MDR, and IVDR services, including Product Classification and seven Smart Builders, that deliver critical assistance to companies transitioning to the new regulatory scheme.

11,000+

Device companies active on RAMS

8,000+

Regulatory certificates tracked

100k+

DEVICES PLACED ON THE MARKET WITH EMERGO

Explore our Highlighted Features

Product Classification

Streamline the first step to market access with device classification and verification.

Smart Builder

Quickly, easily create MDD / MDR / IVDR documents and FDA 510(k) submissions

Registration Tracker

Simplify your work, avoid missed renewals, and save time with automated registration and certification tracking

Regulatory Watch

Keep track of regulatory changes and how they impact your registrations

Regulatory Intelligence

Explore new markets with regulatory insights categorized by country, device type, and device class

Greenlight Guru eQMS

A connected quality ecosystem where every record of your QMS is organized, centralized, and traceable

Global representation through one point of contact

Medical device regulations in most countries require foreign manufacturers to appoint an in-country representative. With offices around the world, Emergo can serve as your in-country representative in the US and Europe and beyond.

Ready for the next step? Register today.

Ready for the next step? Register today.