The MDR Technical Documentation File Builder is the latest tool added to RAMS – Regulatory Affairs Management Suite, our software-as-a-service platform for digital regulatory solutions. This feature offers step-by-step guidance on building documentation to EU MDR specifications. The MDR Technical Documentation File Builder:

• Guides users through creation of a Technical Documentation File
• References eQMS to seamlessly update documentation
• Enables collaboration with colleagues to improve efficiency
• Limits errors by using a Keyword system to auto-populate critical data throughout the document

EMERGO by UL experts are also available to provide ad hoc support for any questions that arise during use of the tool. For a visual guide to how the MDR Technical Documentation File Builder and the FDA 510(k) Builder work, watch this RAMS Smart Builder overview video➔

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