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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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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.

 

 

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17,000+

DEVICE COMPANIES ACTIVE ON RAMS

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13,000+

REGULATORY CERTIFICATES TRACKED

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100k+

DEVICES PLACED ON THE MARKET WITH EMERGO

 

 

Features of our regulatory compliance management software

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Emergo Pro Bundles

Simple solutions that target your medical device or IVD expansion

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Product Classification

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

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Smart Builder

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

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Registration Tracker

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

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Regulatory Watch

Keep track of regulatory changes and how they impact your registrations

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Regulatory Intelligence

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

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Affiliate Services

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

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Regulatory Reports

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

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Global Fee Finder

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

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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.

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"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.

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"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

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"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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