Global representation through one point of contact
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.
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