Medical Device Regulation (MDR)
Create your Technical Documentation File (TDF) and Clinical Evaluation Report/Plan for MDR Compliance
Medical Device Directive (MDD)
Copy amd import features that sync bewteen projects from MDD to MDR regulatory requirements.
Logic-based questions that auto-populate data to streamline work and can eliminate errors that delay approval.
Flexible Documentation Tools
Creates a living document for your technical documentation and insert references to your Quality Management System.
See how it works
Developed by experts at Emergo by UL, RAMS offers a growing portfolio of EU MDD, MDR, and IVDR services that deliver critical assistance to companies transitioning to the new
"As someone who never has filed a 510(k) before, RAMS Smart Builder made the process remarkably straightforward. Our submission process was over 900 pages, and I can't imagine assembling all those documents without Smart Builder. Furthermore, we passed the FDA Acceptance Review on our first try."
Stephen Kita, Project Engineer | ZXS Medical, LLC
“Now that we have RAMS, we no longer worry about missing registration renewal deadlines, helping us save money and avoid unnecessary work and problems with regulatory authorities."