New EU Technical File Builder designed for EU MDR compliance

Fast, efficient system provides a clear structure to create medical device technical documentation compliant with MDR 2017/745

Experience you can trust

Conceived and developed by experts at Emergo by UL, the RAMS suite of software helps medical device companies monitor the latest changes, prepare FDA 510(k) submissions, coordinate registrations and renewals, facilitate regulatory procedures, and more.

Experience you can trust

Conceived and developed by experts at Emergo by UL, the RAMS suite of software helps medical device companies monitor the latest changes, prepare FDA 510(k) submissions, coordinate registrations and renewals, facilitate regulatory procedures, and more.

>7,000

Device companies active on RAMS

>8,000

Regulatory certificates

>100,000

Medical devices placed on market in the past 20 years

Highlighted Features

Regulatory Updates

Tap into weekly insights from a team of global experts that keep you informed.

Simplify Market Expansion

High-level market overviews get you started, supported by detailed documentation for growth into new markets.

Valuable Tools

Interactive planning tools take the mystery out of FDA 510(K) approval.

Find Answers

Searchable database harnesses the expertise from a team of global RA experts.

Gain Insights

See the "big picture" with clear, automatically generated reports on your registrations.

Smart Builder

Create 510(k) and MDR Technical Documentation File using guided templates

Ready for the next step? Register today.

Ready for the next step? Register today.