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Industry Focus

The healthcare industry is changing and we have the breadth of expertise to help
you evolve with it.

Overview
 * MedTech
 * HealthTech
 * Pharmaceuticals / BioTech
 * Healthcare Providers
 * Health & Wellness Retail

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Services

Comprehensive service offerings at every point in the product life cycle.

Overview
 * Market Access
 * Human Factors Research & Design
 * Privacy & Security Services

RAMS

A platform of digital products to improve, simplify and automate RA/QA
activities

Learn more
OPUS

Emergo by UL's new human factors tool - provides training, tools, and resources.

Learn more
Software

Our software tools offer digital regulatory monitoring for medical device
compliance and access to human factors engineering tools.

Overview
 * RAMS
   * Emergo Pro Bundles
   * Product Classification
   * Smart Builder
   * Registration Tracker
   * Regulatory Watch
   * Regulatory Intelligence
   * Affiliated Services
   * Regulatory Reports
   * Global Fee Finder
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   * Documents
   * Tools


News

The latest industry news and insights from our global team.

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RADAR

Stay informed with the most read RA/QA medical device newsletter.

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TalkingPoints

TalkingPoints is a round-up of news, insights, and resources about human factors
and usability for medical devices, IVDs, combination products, and more.

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Resources

Information and tools to advance your business.

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Our global consulting team works from 20+ offices on six continents.

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REGULATORY AFFAIRS MANAGEMENT SUITE

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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.

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2:21











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.

Log in or sign up

 


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.

Sign up

 

 


17,000+

DEVICE COMPANIES ACTIVE ON RAMS


13,000+

REGULATORY CERTIFICATES TRACKED


100K+

DEVICES PLACED ON THE MARKET WITH EMERGO

 

 


FEATURES OF OUR REGULATORY COMPLIANCE MANAGEMENT SOFTWARE

EMERGO PRO BUNDLES

Simple solutions that target your medical device or IVD expansion

Learn more >

PRODUCT CLASSIFICATION

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

Learn more >

SMART BUILDER

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

Learn more >

REGISTRATION TRACKER

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

Learn more >

REGULATORY WATCH

Keep track of regulatory changes and how they impact your registrations

Learn more >

REGULATORY INTELLIGENCE

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

Learn more >

AFFILIATE SERVICES

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

Learn more >

REGULATORY REPORTS

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

Learn more >

GLOBAL FEE FINDER

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

Learn more >

 

 

 


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.

Learn more

 



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

View FAQs

 


THE REGULATORY COMPLIANCE MANAGEMENT SOLUTION TRUSTED BY MEDICAL DEVICE
COMPANIES GLOBALLY.

"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.

"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

"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

"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

"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

 

 


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RAMS
A platform of digital products to improve, simplify and automate RA/QA
activities.
OPUSTM
Emergo by UL's new human factors tool - provides training, tools, and resources.
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