New MDD Smart Builder now available
New MDD Smart Builder now available
Supports compliance to MDD and prepares for seamless transition to MDR
Experience you can trust
Experience you can trust
Developed by experts at Emergo by UL, the RAMS suite of software helps device companies monitor the latest changes, prepare FDA 510(k) and MDR TD file submissions, coordinate registrations and renewals, facilitate regulatory procedures, and more.
Experience you can trust
Experience you can trust
Developed by experts at Emergo by UL, the RAMS suite of software helps device companies monitor the latest changes, prepare FDA 510(k) and MDR TD file submissions, coordinate registrations and renewals, facilitate regulatory procedures, and more.
>8,500
>8,500
Device companies active on RAMS
>8,000
>8,000
Regulatory certificates
>100,000
>100,000
Medical devices placed on market in the past 20 years
Highlighted Features
Highlighted Features
Smart Builder
Smart Builder
Quickly, easily create MDD Tech Files, MDR Tech Documents, and FDA 510(k) submissions
Regulatory Updates
Regulatory Updates
Tap into weekly insights from a team of global experts that keep you informed.
Simplify Market Expansion
Simplify Market Expansion
High-level market overviews get you started, supported by detailed documentation for growth into new markets.
Find Answers
Find Answers
Searchable database harnesses the expertise from a team of global RA experts.
Gain Insights
Gain Insights
See the "big picture" with clear, automatically generated reports on your registrations.
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