Dec 9, 2020

Emergo by UL has launched important new content in its Regulatory Affairs Management Suite (RAMS) automated platform for medical device and IVD RA/QA management and compliance monitoring.

The new RAMS release includes new and enhanced capabilities boosting market research, streamlined regulatory documentation and data security.

  • New Smart Builder documentation management tools cover Material and Equipment document requirements for the ANVISA Registro medical device market access route in Brazil. The Smart Builder tool allows users to fill out required forms in English and then submit technical file documentation in Portuguese with translation support from Emergo by UL, and also enables users to generate Letters of Authorization needed for ANVISA registration.
  • The Regulatory Intelligence module now provides access to market intelligence resources including regulatory process charts and FAQs.
  • RAMS Product Classification coverage now includes two new markets—Colombia and New Zealand—as well as the European In-vitro Diagnostic Medical Devices Regulation (IVDR). Users now also have access to expanded options for downloadable EU market insights including EU Regulatory Essentials Reports and EU Classification Rationales.
  • A new RAMS premium service, Regulatory Pathway, enables users to directly access detailed medical device and IVD regulatory reports to help determine registration and approval requirements in specific markets.

In addition, the RAMS update features enhanced security features to ensure safety of users’ accounts and data, including two-factor authentication.

The RAMS digital RA/QA platform now has more than 12,000 active users, and more than 8,000 regulatory certificates are tracked using the platform. Learn more here.

Related resources:


  • Stewart Eisenhart