EMERGO by UL Releases RAMS 2.5, Expanding Automated Medical Device RA/QA Capabilities

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Latest version of the digital RA/QA software platform includes two new EU Smart Builders, a classification service, and free regulatory resources for eight new markets

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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.

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:

  • Two new Smart Builders to aid with creating, collaborating on, and formatting an EU MDR Clinical Evaluation Report (CER) or Clinical Evaluation Plan (CEP). These expand the existing Smart Builder portfolio, which consists of US FDA 510(k), EU MDD CER, MDD Technical File & Design Dossier, and MDR Technical Documentation File submissions. The MDD and MDR builders are compliant with current and upcoming European regulatory schemes to help ease transition between the two.
  • The Product Classification tool, which empowers users to determine the classification of a new device or verify an existing classification in minutes. This feature, which is free to use for a limited time, launches with EU classifications and will expand to cover classifications in other markets.
  • Resources including regulatory process charts, country reference documents, and FAQs for eight new markets across Europe and Asia. The additions give RAMS subscribers access to resources covering 36 healthcare markets worldwide.

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.

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Stewart Thomas Eisenhart
EMERGO by UL
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