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Get Step-by-step Regulatory Guides for the EU MDR and IVDR Markets

A powerful tool from Emergo by UL streamlines RA/QA documentation to get your device on market faster and simplify the transition to new European Union regulations.

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Medical Device Regulation (MDR)

Create your Technical Documentation File (TDF) and Clinical Evaluation Report/Plan for MDR Compliance

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Medical Device Directive (MDD)

Copy amd import features that sync bewteen projects from MDD to MDR regulatory requirements.

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In Vitro Diagnostic Regulation (IVDR)

Build a Technical Documentation File and Performance Evaluation Report/Plan compliant with IVR 2017/746

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Eliminate Errors

Logic-based questions that auto-populate data to streamline work and can eliminate errors that delay approval.

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Flexible Documentation Tools

Creates a living document for your technical documentation and insert references to your Quality Management System.

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Get on Market Faster

Save time and money by leveraging your existing resources to speed up access to EU markets.

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

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ZSX Logo

"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

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“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."

Kristian Nielsen | Sr. Manager, Regulatory and Clinical Affairs