EMERGO by UL launches RAMS 2.0 for automated medical device regulatory affairs and quality management

USA - English

• USA - English

AUSTIN, Texas, Sept. 23, 2019 /PRNewswire-PRWeb/ -- EMERGO by UL, a global medical device and healthcare technology consultancy, has launched a new version of its industry-leading Regulatory Affairs Management Suite (RAMS) digital platform, RAMS 2.0, that features expanded regulatory affairs and quality management capabilities to help medical device manufacturers maintain their products in markets worldwide. RAMS 2.0 builds upon RAMS-TRACK (RAMS 1.5), EMERGO by UL's cutting-edge medical device registration tracking tool rolled out in 2018.

The RAMS 2.0 platform now includes the following tools and capabilities to support streamlined RA/QA operations for medical device companies:

• A new Pathway tool featuring regulatory updates and intelligence based on more than 20 years of Emergo consulting expertise covering more than 20 markets across North and South America, Europe, Asia, the Middle East and Australia
• Automated regulatory notifications and alerts organized according to markets where each RAMS user's device is commercialized
• Access to regulatory intelligence resources including process charts, market strategy reports, calculators to estimate time and cost for market compliance, and links to registration and guidance documents from market regulators
• "Big picture" global device registration overviews via RAMS automated visual reports

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