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Device Registration

Emergo can help you obtain medical device approval and start selling in 20+ markets worldwide. We have successfully submitted applications for thousands of devices.

Introducing RAMS

The future of regulatory affairs.

See how RAMS-TRACK can help you simplify medical device registration management.

The Regulatory Affairs Management Suite (RAMS) is a platform of digital products that improve, simplify, and automate RA/QA activities for medical device manufacturers.

Conceived and developed by industry experts at Emergo by UL, the RAMS platform helps device companies keep up with the latest regulatory changes, coordinate registrations and renewals, facilitate regulatory procedures, and more.

RAMS-TRACK is the first of several products that will make up the RAMS platform.

Visit our RAMS-Track website to know more.

Questions? Request more information from our specialists

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Device Registration

Australia | Device Registration

In Vitro Diagnostic (IVD) Registration in Australia

Australia | Device Registration

Medical Device Registration with the Australian TGA

Hong Kong | Device Registration

Medical Device Registration in Hong Kong

Malaysia | Device Registration

Medical Device Registration in Malaysia

New Zealand | Device Registration

MedSafe Medical Device Registration in New Zealand

Russia | Device Registration

Medical Device and IVD Registration in Russia

South Korea | Device Registration

Technical File Preparation for Korea MFDS Submissions

United States | Device Registration

US FDA 510(k) Consulting for Medical Devices and IVDs

Worldwide | Device Registration

IVD Registration and Approval Consulting

Device Registration

MHRA Guidance on a No-Deal Brexit