Skip to main content
Switch Language
graphic depicting a digital world

Regulatory Affairs Management Suite

RAMS is a regulatory compliance management solution that helps you understand and manage the always-evolving landscape of medical device regulations, compliance and representation.

Log in to RAMS Sign up

RAMS adds new features to become a better regulatory compliance software

Experience the new free Global Fee Finder tool, three Mexico Equivalency Route Smart Builders, and IVDR Regulatory Essentials reports.


A regulatory compliance software developed by experts, but made for you

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.



Icon of a company



Icon of a computer



Icon of a checklist





Features of our regulatory compliance management software

Illustration of papers in a box

Emergo Pro Bundles

Simple solutions that target your medical device or IVD expansion

Learn more >

Flow Chart

Product Classification

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

Learn more >

Gear in front of papers

Smart Builder

Quickly and easily create MDD / MDR / IVDR documents as well as technical documentation for Brazil and Mexico.

Learn more >

Paper with graph

Registration Tracker

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

Learn more >

Ringing bell icon

Regulatory Watch

Keep track of regulatory changes and how they impact your registrations

Learn more >

Monitor with graph

Regulatory Intelligence

Plan your expansion with process charts and FAQs comprising a global knowledge base

Learn more >

Laptop with a lightbulb

Affiliate Services

Discover Greenlight Guru's eQMS platform and learning management from ComplianceWire®

Learn more >

Winding path flow chart

Regulatory Reports

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

Learn more >

Globe with a magnifying glass

Global Fee Finder

Quickly estimate registration and submission fees for 22 markets worldwide with this free tool

Learn more >




Business partners discussing business.

Global representation through one compliance management solution

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.


Get answers about registering, renewing accounts and what tools you’ll find in RAMS.


The regulatory compliance management solution trusted by medical device companies globally.

Prytime Medical Devices logo
"510(k) Builder enabled us to compose a 510(k) with clinical data within 10 days and we obtained first pass screening acceptance in 6 days."

Brian Young
SVP, Quality and Regulatory, Prytime Medical Devices, Inc.

ZSX logo
"Our submission was over 900 pages, but the RAMS 510(k) Builder made the process remarkably straightforward. Furthermore, we passed the FDA Acceptance Review on our first try."

Stephen Kita
Project Engineer, ZSX Medical, LLC

Fujifilm SonoSite logo
"Now that we have RAMS, we no longer worry about missing registration renewal deadlines, helping us save money and avoid unnecessary work and problems with regulatory authorities."

Kristian Nielsen
Sr. Manager, Regulatory and Clinical Affairs

Cooper Medical Logo
"RAMS helps us avoid wasting time searching for registration details in notes or spreadsheets. With all the information in one place, we can easily prepare renewals without having to spend hours looking for the necessary details."

Paul Geuser
Document Control Manager

Mavig logo
"With RAMS, our small team can now easily manage a large number of registrations and certificates with less effort, enabling us to focus our work on bringing new products to market."

Ludwig Herrmann
Quality Manager



Ready for the next step?

Sign up today.

Sign up