RAMS 2.5 adds new premium services and country resources
RAMS 2.5 adds new premium services and country resources
The latest version of the digital RA/QA platform includes new MDR CEP and CER Smart Builders, a Product Classification tool, plus resources for eight markets.
Experience you can trust
Experience you can trust
Developed by experts at Emergo by UL, RAMS offers a growing portfolio of EU MDD and MDR services, including Product Classification and five Smart Builders, that deliver critical assistance to companies transitioning to the new regulatory scheme.
Experience you can trust
Experience you can trust
Developed by experts at Emergo by UL, RAMS offers a growing portfolio of EU MDD and MDR services, including Product Classification and five Smart Builders, that deliver critical assistance to companies transitioning to the new regulatory scheme.
>10,000
>10,000
Device companies active on RAMS
>8,000
>8,000
Regulatory certificates tracked
>100,000
>100,000
Medical devices placed on market in the past 20 years
Highlighted Features
Highlighted Features
Product Classification
Product Classification
Streamline the first step to market access with device classification and verification.
Registration Tracker
Registration Tracker
Simplify your work, avoid missed renewals, and save time with automated registration and certification tracking
Regulatory Intelligence
Regulatory Intelligence
Explore new markets with regulatory insights categorized by country, device type, and device class
Greenlight Guru eQMS
Greenlight Guru eQMS
A connected quality ecosystem where every record of your QMS is organized, centralized, and traceable
Trusted globally by medical device companies.
Trusted globally by medical device companies.
"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
Stephen Kita
Project Engineer, ZSX Mediccal
Project Engineer, ZSX Mediccal
Trusted globally by medical device companies.
Trusted globally by medical device companies.
“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
Kristian Nielsen
Sr. Manager, Regulatory and Clinical Affairs
Sr. Manager, Regulatory and Clinical Affairs
Trusted globally by medical device companies.
Trusted globally by medical device companies.
“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
Paul Geuser
Document Control Manager
Document Control Manager
Trusted globally by medical device companies.
Trusted globally by medical device companies.
“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
Ludwig Herrmann
Quality Manager
Quality Manager
Trusted globally by medical device companies.
Trusted globally by medical device companies.
"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
Brian Young
SVP, Quality and Regulatory, Prytime Medical
SVP, Quality and Regulatory, Prytime Medical