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.
DEVICE COMPANIES ACTIVE ON RAMS
REGULATORY CERTIFICATES TRACKED
DEVICES PLACED ON THE MARKET WITH EMERGO
Features of our regulatory compliance management software
Streamline the first step to market access with device classification and verification
Quickly, easily create MDD / MDR / IVDR documents and FDA 510(k) submissions
Simplify your work, avoid missed renewals, and save time with automated registration and certification tracking
Keep track of regulatory changes and how they impact your registrations
Plan your expansion with process charts and FAQs comprising a global knowledge base
Discover Greenlight Guru's eQMS platform and learning management from ComplianceWire®
Explore new markets with regulatory insights categorized by country, device type, and device class
Global Fee Finder
Quickly estimate registration and submission fees for 22 markets worldwide with this free tool
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.
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."
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."
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."
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."
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."