AUSTIN, Texas, Sept. 23, 2019 /PRNewswire-PRWeb/ -- EMERGO by UL, a global medical device and healthcare technology consultancy,
The RAMS 2.0 platform now includes the following tools and capabilities to support streamlined RA/QA operations for medical device companies:
EMERGO by UL will continue deploying new features and capabilities for RAMS. For example, new US FDA 510(k) submission and Clinical Evaluation Report (CER) creation tools will be added to the RAMS digital platform in early 2020 following integration of technologies developed by Right Submission, which EMERGO by UL acquired on August 31, 2019. These and additional features will further automate and simplify workflows for medical device companies, and improve productivity for busy Regulatory Affairs professionals.
With more than 2,000 users currently on the platform, RAMS now has the largest user base of any digital regulatory affairs management system for medical and combination products available.
Medical device manufacturers may set up free RAMS accounts to learn how automated RA/QA technologies can help them bring their products to market faster and more cost-effectively. As a limited time launch promotion, we are offering free access through December 2020, to the premium features available on RAMS 2.0. RAMS 2.0 will be officially launched at the 2019 annual Regulatory Affairs Professional Society (RAPS) Regulatory Convergence Conference held September 21-24, 2019 in Philadelphia.
"Effective RA/QA management across multiple medical device markets requires substantial resources that many manufacturers simply don't have internally," says Michael van der Woude, General Manager, Market Access at EMERGO by UL. "RAMS provides companies the ability to monitor regulatory changes in all markets where they sell, and act quickly to maintain compliance when changes occur."
Anil Vasireddy, Director, Product Development at EMERGO by UL, adds, "The RAMS platform combines best-in-class digital tools for manufacturers to monitor their device registrations with access to regulatory intelligence and strategy reports, as well as insights from Emergo regulatory experts active in more than 20 major medical device markets globally."
About Emergo by UL EMERGO by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success. With a presence on six continents, we can provide real-time service and on-the-ground expertise. Learn more about how we can help you grow at EMERGObyUL.com.
SOURCE EMERGO by UL