AUSTIN, Texas, Aug. 3, 2020 /PRNewswire-PRWeb/ — EMERGO by UL, a global medical device and healthcare technology consultancy, released version 2.5 of Regulatory Affairs Management Suite (RAMS), a digital platform that helps manufacturers of medical devices and IVDs to streamline market access and keep track of registrations and regulatory developments. There are now 10,000 medical device and IVD manufacturers active on RAMS and relying on the platform’s blend of free and premium quality assurance and regulatory affairs management services.
New features in RAMS 2.5 include:
Since the first Smart Builder for US FDA 510(k) submissions was released in January 2020 as part of the RAMS 2.1 release, EMERGO by UL has continued to expand the scope of this service to include additional regulatory documentation. Coming soon is an EU MDR Class I Self-Certified CER Smart Builder, along with offerings later in 2020 covering medical device and IVD markets in Mexico and Brazil.
Medical device and IVD manufacturers may set up free RAMS accounts to explore how the tools available on the platform assist them in bringing devices to market and maintaining compliance with greater speed and less cost and effort. Users may also sign up for the eQMS partner service offered by Greenlight Guru, which applies digital automation tools to implement robust quality management system (QMS) capabilities.
“This is our most significant release since the introduction of the first Smart Builder with RAMS 2.1, and arguably since we launched RAMS 2.0 to revolutionize our RA/QA offerings,” said Michael van der Woude, Director and General Manager, Market Access, at EMERGO by UL. “With RAMS 2.5 we greatly add to the depth and breadth of our EU submission tools, and open up a number of significant emerging healthcare markets.”
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
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