EMERGO by UL launched a new version of its 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.
The RAMS 2.0 platform includes tools and capabilities to support streamlined regulatory affairs/quality assurance (RA/QA) operations for medical device companies:
- Pathway tool – Regulatory updates and intelligence based on 20+ years of Emergo consulting covering 20+ markets across North and South America, Europe, Asia, the Middle East, and Australia
- Automated regulatory notifications, alerts – Organized according to markets where each RAMS user’s device is commercialized
- Access to regulatory intelligence resources – Includes process charts, market strategy reports, time and cost for market compliance estimate calculators, and links to registration, 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, such as a new U.S. FDA 510(k) submission and Clinical Evaluation Report (CER) creation tool will be added in early 2020 following integration of technologies developed by Right Submission. These and additional features will further automate and simplify workflows for medical device companies, and improve productivity for busy Regulatory Affairs (RA) professionals.
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 officially launched last month at the 2019 annual Regulatory Affairs Professional Society (RAPS) Regulatory Convergence Conference that was held in Philadelphia.